Sandfort TGM et al.

Journal of the International AIDS Society 2020, 23(S6):e25600

http://onlinelibrary.wiley.com/doi/10.1002/jia2.25600/full | https://doi.org/10.1002/jia2.25600

RESEARCH ARTICLE

The feasibility of recruiting and retaining men who have sex

with men and transgender women in a multinational prospective
HIV prevention research cohort study in sub-Saharan Africa
(HPTN 075)
Theodorus GM Sandfort1,§ , Erica L Hamilton2 , Anita Marais3, Xu Guo4, Jeremy Sugarman5 , Ying Q Chen4,
Vanessa Cummings6, Sufia Dadabhai7, Karen Dominguez8, Ravindre Panchia3, David Schnabel9, Fatima Zulu7,
Doerieyah Reynolds8, Oscar Radebe10, Calvin Mbeda9 , Dunker Kamba11, Brian Kanyemba8, Arthur Ogendo9,
Michael Stirratt12, Wairimu Chege13, Jonathan Lucas2, Maria Fawzy14, Laura A McKinstry4 and
Susan H Eshleman6
§
Corresponding author: Theo GM Sandfort, New York State Psychiatric Institute, 1051 Riverside Drive, Unit 15, New York, New York 10032 USA. Tel: +1 646 774
6946. ([email protected])

Abstract
Introduction: Men who have sex with men (MSM) and transgender women (TGW) in sub-Saharan Africa (SSA) are profoundly
affected by HIV with high HIV prevalence and incidence. This population also faces strong social stigma and legal barriers,
potentially impeding participation in research. To date, few multi-country longitudinal HIV research studies with MSM/TGW
have been conducted in SSA. Primary objective of the HIV Prevention Trials Network (HPTN) 075 study was to assess feasibil-
ity of recruiting and retaining a multinational prospective cohort of MSM/TGW in SSA for HIV prevention research.
Methods: HPTN 075, conducted from 2015 to 2017, was designed to enroll 400 MSM/TGW at four sites in SSA (100 per
site: Kisumu, Kenya; Blantyre, Malawi; Cape Town, South Africa; and Soweto, South Africa). The number of HIV-positive per-
sons was capped at 20 per site; HIV-positive persons already in care were excluded from participation. The one-year study
included five biobehavioural assessments. Community-based input and risk mitigation protocols were included in study design
and conduct.
Results: Of 624 persons screened, 401 were enrolled. One in five participants was classified as transgender. Main reasons for
ineligibility included: (a) being HIV positive after the cap was reached (29.6%); (b) not reporting anal intercourse with a man in
the preceding three months (20.6%); and (c) being HIV positive and already in care (17.5%). Five (1.2%) participants died dur-
ing the study (unrelated to study participation). 92.9% of the eligible participants (368/396) completed the final study visit and
86.1% participated in all visits. The main, overlapping reasons for early termination included being (a) unable to adhere to the
visit schedule, predominantly because of relocation (46.4%), and (b) unable to contact the participant (32.1%). Participants
reported strong motivation to participate and few participation barriers. Four participants reported social harms (loss of confi-
dentiality and sexual harassment by study staff) that were successfully addressed.
Conclusions: HPTN 075 successfully enrolled a multinational sample of MSM/TGW in SSA in a prospective HIV prevention
research study with a high retention rate and few documented social harms. This supports the feasibility of conducting large-
scale research trials in this population to address its urgent, unmet HIV prevention needs.
Keywords: HIV; closed cohort study; men who have sex with men; transgender women; sub-Saharan Africa

Additional Supporting information may be found online in the Supporting Information tab for this article.

Received 17 January 2020; Accepted 21 July 2020

Copyright © 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium,
provided the original work is properly cited.

1 | INTRODUCTION and transgender women (TGW) and their role in the epidemic.
Earlier HIV research and public health efforts in SAA have
In sub-Saharan Africa (SSA), there is increasing recognition of focused on heterosexual transmission, since that is the main
the HIV burden among men who have sex with men (MSM) mode of HIV transmission this region [1,2]. However, multiple

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epidemiologic studies now show that gay, bisexual and other multinational prospective cohort [25]. Although the primary
MSM in SSA are profoundly affected by HIV. The first HIV focus of HPTN 075 was on MSM, TGW were not excluded
prevalence study among MSM, conducted in 2004 in Senegal, because some TGW in SSA socialize and identify with MSM
reported a prevalence of 21.5% [3]; pioneering work with or identify as “gay.” [7,26] This report describes the prepara-
MSM has also been conducted in Kenya [4]. The observed tion of the HPTN 075 study sites for study implementation,
HIV prevalence among MSM in SSA ranges from 4.1% to recruitment methods and results, retention of study partici-
49.5% [5-9]. A systematic review in 2012 estimated the over- pants and occurrence of social harms.
all HIV prevalence among MSM in SSA to be 18% [10]. A
more recent review [11] showed that HIV testing among
2 | METHODS
MSM in SSA has significantly increased over time. However,
HIV status awareness is still low, ranging from 6.7% in coun-
2.1 | Study design and population
tries with the most severe legislation against the lesbian, gay,
bisexual and transgender communities, to 22.0% in countries Study participation included biobehavioural assessments at
with the least severe legislation. screening and at five subsequent study visits over one year.
Prevention trials are urgently needed to evaluate HIV pre- Four sites participated: Kisumu, Kenya; Blantyre, Malawi; and
vention interventions among MSM/TGW in SSA [12]. How- Cape Town and Soweto, South Africa. HIV-positive and HIV-
ever, more information is needed about the feasibility of negative persons were eligible to enrol; the number of HIV-
conducting such trials in this population. Since the early positive persons was capped at 20 per site. Although TGW
2000s, several studies have been conducted among MSM in could participate, there were no specific efforts to recruit
SSA, demonstrating the feasibility of recruiting this population; them. The same considerations applied to male sex workers.
however, most of these studies had a cross-sectional design Screening and enrolment started in June 2015 and ended in
(e.g. [13,14]). The limited number of longitudinal cohort stud- July 2016. Data collection ended in July 2017.
ies conducted generally included open cohorts at single sites
or in individual countries (e.g. [15,16]). Less is known about
2.2 | Eligibility criteria
the feasibility of retaining MSM in a multi-national prospective
cohort over time (prior multi-country longitudinal studies with Main eligibility criteria included: (a) assigned male sex at birth;
MSM in SSA were limited to six-month follow-up [17]). Infor- (b) 18 to 44 years old; (c) reporting at least one act of anal
mation is also needed about the feasibility of achieving optimal intercourse in the previous three months with a person
adherence to study visits and preventing social harms in this reported by the participant to be biologically male; (e) three
population. concordant HIV test results at screening and (d) willing to
Maintaining a cohort of MSM/TGW in SSA for HIV preven- undergo HIV testing throughout the study and receive test
tion research could be challenging for several reasons, includ- results. An optimal evaluation of the study aim would require
ing physical, social and legal risks that are likely to interfere a sample of persons who were na€ıve to HIV research. For that
with study retention. Same-sex behaviour is criminalized in reason, persons who previously participated in a biomedical
most SSA countries, with sentences ranging up to the death and/or behavioural intervention or cohort study for HIV or
penalty [18]. Although enforcement of these laws varies by sexually transmitted infections (STIs) were excluded; co-enrol-
country, participation in MSM/TGW research could imply dis- ment in such studies was not permitted. The study protocol
closure of illegal behaviour and could thus have legal reper- was amended to ensure that participants would have access
cussions. Also, compared to other parts of the world, to oral pre-exposure prophylaxis (PrEP) when it became acces-
countries in SSA are among the least accepting of same-sex sible at some sites (e.g. through demonstration projects);
sexuality [19]. Experiences with homophobia, including vio- although several PrEP referrals were made, no participants
lence and blackmail, are well-documented in this population reported initiating PrEP. To evaluate uptake of care, HIV-
[20,21]. Recruiting and retaining MSM/TGW, especially for positive participants who reported already being in HIV care
studies in a medical context, also require gaining trust. Prior or on antiretroviral treatment (ART) were also excluded from
discriminatory experiences in medical settings may lead MSM/ study participation.
TGW to fear insensitive treatment by study staff and inappro-
priate disclosure of sexual practices or HIV status [22,23].
2.3 | Procedures
There are also risks for research staff and study integrity.
For example, being associated with a study of MSM/TGW Given the potential risks associated with the study, each study
might be interpreted as condoning or promoting same-sex site was instructed to develop a site-specific risk-mitigation
sexuality. There is also the possibility of physical attacks at plan (RMP; Appendix S1), guided by international guidelines
study sites and negative media coverage of the study or the for HIV prevention trials [27,28], research with MSM in
study population. In other studies of MSM in SSA, offices have rights-constrained environments [29] and ethical guidance
been attacked by community members and staff arrested, with from the HPTN [30]. This approach was intended to help both
the allegation that same-sex sexual activities were being pro- researchers and community organizations safely conduct
moted and that young people were being recruited to become meaningful research in challenging social, political and human
MSM [24]. These types of social harms have not been system- rights contexts; this included use of a checklist of factors to
atically studied. be considered in the design, conduct, and implementation of
In this context, the HIV Prevention Trials Network (HPTN) the study.
initiated the HPTN 075 study, with the objective to assess the Preparation of RMPs included: (a) establishing ongoing
feasibility of recruiting and retaining 400 MSM/TGW in a engagement with the MSM community and local MSM

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organizations; (b) building rapport and support with the gen- Facebook or appointment cards); arrangement of transporta-
eral community, including health authorities, media, religious tion to the study site or reimbursement of transportation
leaders and local police; (c) creating a Community Advisory costs; home visits based on regularly updated locator informa-
Board (CAB); (d) forming a Protocol Advisory Committee tion; a welcoming study site environment (courteous treat-
(PAC) for active oversight of study implementation that ment by staff; addressing participants by preferred names and
included members of the MSM community and persons with pronouns; food and refreshments; magazines, video and Inter-
direct expertise on MSM issues; (e) developing procedures for net access in waiting rooms); free medical services and contin-
ensuring study participants’ confidentiality, that included a ued outreach and support through community events, such as
requirement for staff to sign confidentiality agreements and educational events, beach days, weekend camps and pageants.
interact with participants in a non-judgemental, MSM-affirming Some study participants were not interested in these events
way; (f) sensitizing relevant stakeholders, including study staff, due to risk of disclosure.
and informing them that disclosing any information about par- Behavioural assessments included collection of demographic,
ticipants was subject to disciplinary measures, up to termina- behavioural, psychosexual and socioeconomic data, and inter-
tion; (g) developing procedures for responding to problems est in potential HIV prevention strategies. Evaluation of study
and establishing an emergency committee to facilitate a direct participation included barriers and facilitators to participation,
response to any urgent situations, including a communication study burden and social harms and benefits from participation.
plan; and (h) systematically assessing possible social harms at As much as possible, assessment tools were adopted that
study visits, developing a priori responses for addressing such were successfully used in this population in SSA. Other mea-
harms and training the study staff on the collection of social sures were adapted from existing assessments.
harm data and reporting. The preparation of these RMPs likely After study completion, information was collected from vari-
facilitated the process of obtaining in-country ethics approval ous stakeholders, including research staff, via questionnaires
for the study; the study’s focus did not cause any difficulties. and in-person interviews to characterize the process at each
HPTN 075 aimed to recruit a diverse sample of MSM at site for building stakeholder support and determining ideal
high risk of acquiring HIV infection. In consultation with the recruitment strategies. In these evaluations, the following
community, each site developed site-specific strategies to pro- topics were addressed: MSM community involvement and
mote study awareness and acceptability and recruitment. This impact; recruitment and retention of participants; ongoing
approach (a) allowed for optimal use of the local community’s community engagement; study site preparation and implemen-
expertise and customization to local circumstances; and (b) tation; incentives and services; CABs/PACs; emergency com-
made it easier to adjust strategies if recruitment outcomes mittee and future research needs.
lagged at specific sites. Various recruitment strategies were
implemented: (a) peer outreach: MSM, hired and trained as
2.4 | Data analysis
peer-outreach workers (from one to eight per site) who
approached potential study participants based on their per- Descriptive statistics were used to characterize study recruit-
sonal knowledge of and connections to the MSM population; ment, enrolment and retention, as well as participant demo-
(b) participant referral: participants were asked to refer graphics, motivation to take part in the study and adverse
friends for participation in the study (not incentivized); (c) incidents. Univariate and multivariable logistic regression
informational sessions about the study; (d) key informant was used to compare characteristics of participants who com-
referral: trusted persons with access to MSM networks dis- pleted all study visits with those who did not complete the
tributed study information and encouraged MSM to partici- study or missed one of more visits. A stepwise model was
pate; and (e) indirect recruitment: distribution of used for multivariable analysis; the significance level for entry
announcements via in person and web-based “gay” venues and and exit of variables in the model was set at 0.3 and 0.35
events. respectively.
Screening for HPTN 075 included administrative proce-
dures, collection of biological samples and HIV and STI testing.
2.5 | Ethics statement
Eligible persons who consented to participate subsequently
had an enrolment visit and follow-up visits at weeks 13, 26, Study sites received approval from their respective institu-
39 and 52. All study visits included structured behavioural tional review boards (IRBs) and the Division of AIDS, National
assessments, HIV risk reduction counselling, assessment of Institute of Allergy and Infectious Diseases. Informed consent
social impacts, collection of biological samples, HIV testing (if was obtained separately for screening and enrolment. Partici-
HIV negative at the prior visit) and medical examinations. STI pants provided written consent at three sites and oral consent
treatment was provided; some participants, if so desired, were at one site, as directed by the local IRB, because signing a
referred to a clinic of their choice; one site offered treatment consent form could lead to unintended disclosure.
to participants’ sexual partners. Condoms and lubricants were
available at each visit. ART adherence assessments and coun-
selling were provided as appropriate. Research participation 3 | RESULTS
was incentivized according to local standards (ranging from $4
to $10 US). Participation of employed participants was facili- A summary of study recruitment and participation outcomes
tated by offering flexible appointment times, including in the is presented in Figure 1. In total, 624 persons were screened;
weekend. 223 were ineligible. The main reasons for ineligibility included:
Sites implemented a variety of retention strategies. These (a) being HIV positive after the cap was reached (n = 66,
included visit reminders (via telephone, text messages, email, 29.6%); (b) not reporting anal intercourse with a man in the

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preceding three months (n = 46, 20.6%); (c) being HIV posi- care, resulting in many persons being excluded (eligibility crite-
tive and already in care (n = 39, 17.5%); (d) past or current ria were not communicated during recruitment or screening;
participation in an HIV study (n = 31, 13.9%) and (e) not one site made clear that they were looking for persons who
returning for enrolment within 30 days of the screening visit were not living with HIV after a substantial number of per-
(n = 29, 13.0%). The time needed to recruit 100 participants sons had to be rejected because they were living with HIV).
varied by site from 18.7 to 39.1 weeks (average 31.1 weeks). Co-enrolment in another HIV-study was observed at one
The average number of participants recruited per week varied study site where a PrEP demonstration study had started. An
by site from 2.6 to 5.3 (overall average 3.5 per week). attempt to prevent co-enrolment by jointly introducing bio-
In reviewing the recruitment process, research staff noted metrics was unsuccessful, because of challenges with obtaining
the importance of collaborating with local MSM communities approval from the respective authorities.
and described most of the recruitment strategies as useful
and successful. Peer referral was less successful at one site
3.1 | Cohort description, motivation to participate
due to stigma and fear of disclosure. Participation incentives
and perceived participation barriers
attracted persons at some sites who were not MSM, reinforc-
ing the need for rigorous screening. All sites noted the impor- Table 1 presents a description of the 401 men enrolled in the
tance of having multiple recruitment strategies. One site study cohort. The average age was 24.2 years (range 18 to
observed that specific efforts could have led to a better rep- 44 years). Seventy-one (17.8%) participants tested positive for
resentation of older and more wealthy participants. A common HIV infection at enrolment (one participant had inconclusive
challenge was the stringent exclusion criterion of being in HIV HIV test results). Most participants (62.4%) identified as gay;

Screened, N = 624 Ineligible: n = 223

Visit 1/Enrollment
Eligible and enrolled:
n = 401

Did not return: n = 8

Deceased: n = 3

Visit 2/Week 13
Participated: Missed:
n = 381 n = 7 + 2†

Did not return: n = 3

Deceased: n = 2

Visit 3/Week 26
Participated: Missed:
n = 370 n = 14 + 1†

Did not return: n = 5

Visit 4/Week 39
Participated: Missed:
n = 368 n = 12

Did not return: n = 12

Visit 5/Week 52
Participated:
n = 368

Figure 1. Overview of screening and study participation in HPTN 075. †Visits of men who returned for at least one follow-up visit but did
not complete Visit 5.

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one in five (20.0%) identified as female or transgender (in line two murders) were determined by local research staff, after
with recommended procedures [31,32], these persons were extensive investigation, to be unrelated to study participation.
categorized as TGW). About two-thirds of the participants Of the remaining 396 participants, 368 (92.9%) completed the
(65.6%) had at least completed secondary education. Week 52 Visit and 317 (86.1%) completed all visits; 28 (7.1%)
At screening, most participants expressed a strong motiva- participants did not return after either the Enrolment Visit or
tion to participate in the study. Only two participants any subsequent visit. The main, overlapping reasons for early
responded “no” to the question whether, if enrolled, they study termination included: (a) unable to adhere to the visit
intended to participate in all scheduled assessments. All partici- schedule, predominantly because of relocation (46.4%); (b)
pants indicated that it was likely or very likely that they would unable to contact the participant (32.1%); (c) refusal to partici-
be able to remain in the study for at least one year. Most par- pate further (17.9%) and (d) incarceration (3.6%). The propor-
ticipants described themselves as very (81.1%) or moderately tion of early terminations differed by site, ranging from 0%
(17.0%) committed to this study. In response to the question (Soweto) to 14.0% (Blantyre). A comparison between partici-
how important or unimportant participants considered the pants who terminated early and those who participated in all
study to be for their community, the majority said “very impor- visits, showed that participants in Blantyre and participants
tant” (88.8%; 9.0% said “moderately important” and 2% “slightly with children were more likely to terminate early compared to
important”). In response to an open question about the single participants in Kisumu and those without children respectively
most important reason to participate, one third (33.5%) (Table 3). Study site (Blantyre, compared to Kisumu) was the
reported their interest in receiving HIV counselling and testing, only factor that remained significant in multivariable analysis.
and knowing their status. Participants’ answers frequently Early termination was not associated with any of the percep-
included more than one reason (Table 2). Most participants tions of the study, including perceived barriers to participa-
(96.5%) felt it was easy or very easy to set up study appoint- tion.
ments, make time to come to study visits (91.8%), and travel to Thirty participants missed a total of 36 visits (including
the clinic for study visits (89.3%). The distance that participants three visits by participants who terminated early). The number
had to travel ranged from less than a mile up to 20 miles, with of participants who missed visits varied from two to 18 per
travel times ranging from a few minutes to about 60 minutes. site. Reasons for missed visits, based on the total number of
visits, included (a) unable to schedule a visit, including because
of temporary relocation (55.6 %); (b) unable to contact partici-
3.2 | Retention
pant (25.0%); (c) refused visit (5.6%); (d) incarcerated (2.8%);
Five participants (1.2%) died during the study; the causes of (e) other reasons (11.1%). Compared to participants who
death (one sports injury, one case of malaria, one suicide and completed all visits, participants who missed any visit

Table 1. Characteristics of the study cohort (N = 401)

Kisumu, Kenya Blantyre, Malawi Cape Town, South Africa Soweto, South Africa
(N = 100) (N = 100) (N = 100) (N = 101)
M (median) / n/Na (%) M (median) / n/Na (%) M (median) / n/Na (%) M (median) / n/Na (%)

Age, in years 25.1 (23) 25.2 (24) 23.5 (22) 23.2 (22)
Education
Grade 11 or lower 33/100 (33.0) 45/96 (46.9) 37/100 (37.0) 27/99 (27.3)
Completed Grade 12 38/100 (38.0) 36/96 (37.5) 39/100 (39.0) 56/99 (56.6)
Completed college 29/100 (29.0) 15/96 (15.6) 24/100 (24.0) 16/99 (16.2)
Married/legal partnership 7/100 (7.0) 10/99 (10.1) 8/100 (8.0) 3/100 (3.0)
Any child 28/100 (28.0) 29/99 (29.3) 20/100 (20.0) 10/100 (10.0)
Transgenderb 20/99 (20.2) 27/97 (27.8) 18/100 (18.0) 14/99 (14.1)
Sexual attraction
Men and women 81/100 (81.0) 71/98 (75.4) 36/99 (36.4) 22/100 (22.0)
Men only 19/100 (19.0) 27/98 (27.6) 63/99 (63.6) 78/100 (78.0)
Sexual identity
Bisexual and other 52/100 (52.0) 50/99 (50.5) 27/100 (27.0) 21/100 (21.0)
Gay 48/100 (48.0) 49/99 (49.5) 73/100 (73.0) 79/100 (79.0)
Ever sex with women 77/100 (77.0) 67/99 (67.7) 50/100 (55.0) 30/100 (30.0)
In ongoing same-sex,
Intimate relationship 87/98 (88.8) 90/99 (90.9) 60/95 (63.2) 78/100 (78.0)
HIV positive at screeningc 15/100 (15.0) 16/99 (16.2) 20/100 (20.0) 20/101 (19.8)

M, mean; n, number with characteristic; N, total number.

a
Due to missing values, some n’s do not add up to sample totals; bpersons who identified their gender as female or transgender; cthe HIV status
of one participant could not be determined.

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Table 2. Most important reason for participating in HPTN 075

3.3 | Risk mitigation and social harms
(N = 391)a
Four social harms were reported. Two study participants
Reason % Example reported indecent treatment by a male study nurse (inappro-
priate touching and sexual propositioning). Research staff
Receiving HIV counselling and 33.5 “I needed to know about my quickly contacted these participants to address the issue and
testing; knowing one’s status” apologize; staff followed up to help ensure that the partici-
status pants regained a sense of safety in the study. Site staff were
Receiving HIV risk reduction 30.9 “I will learn how to keep retrained in appropriate behaviour with participants. After a
education myself from HIV and get
thorough investigation, the nurse involved resigned. Explo-
ration with the site’s outreach workers indicated no negative
the protective measures
repercussions in the community. In a different incident, one
and information”
participant left his job because his employer did not allow him
Knowing more about MSM as 20.5 “To get more information
to attend study visits. Finally, one participant reported loss of
a community; meeting new about MSM and my lifestyle confidentiality related to being gay; a co-worker found his
people, gaining support and challenges that we face informed consent form and told colleagues, which was fol-
from other MSM or being as gay people” lowed by homophobic comments from his manager. This man
empowered as MSM considered quitting his job in response. This event resulted in
Learning more about one’s 16.4 “To pass through the medical instructing study staff at all sites to be clear to participants
own health: getting tested tests that would allow me about the risks involved in having a signed consent form and
for other things than HIV, know my health” more clearly offering the option not to take one’s copy.
getting free check-ups and After data collection was completed, discussions among
research staff indicated that the development of the RMPs
receiving treatment
sensitized the sites and prepared research staff to deal with a
Improving one’s general 14.8 “To know more about HIV
range of problems that might occur. One site commented that
knowledge of health, and my health” preparing the RMP had helped them to focus on dealing with
beyond HIV and STIs site emergencies more generally.
Learning about MSM research 10.5 “Because the study involves
or contributing to MSM MSM and I am one of them
research I think I should participate” 4 | DISCUSSION
MSM, men who have sex with men; STIs, sexually transmitted infections. The HPTN 075 study successfully enrolled a large multinational
a
Based on answers to an open question. Some of the participants’
sample of MSM and TGW in SSA in a prospective HIV preven-
answers to the open question included more than one reason.
tion research study with high rates of retention and few docu-
mented social harms. This indicates that longitudinal research
(but completed the Week 52 Visit) were more likely to be with MSM and TGW in SSA is feasible and can be safely con-
younger, to live in Cape Town, to be exclusively attracted to ducted when there is close attention to community engagement
men, to identify as gay and to conceal their sexuality (Table 4). and risk mitigation procedures. These results support future
Sexual identity was the only factor that remained a significant efforts to conduct large-scale HIV prevention research studies
predictor of having missed any visits in multivariable analysis. and trials with MSM and TGW in SSA to address the urgent
Missed visits were not associated with any perceptions of the and unmet HIV prevention needs in this group.
study, including perceived barriers to study participation. HPTN 075 represents one of the largest, longest, prospec-
Research staff described the implemented retention activities tive, multi-country closed-cohort research study with MSM
as effective and necessary. Continuing community involvement and TGW in SSA to date. The study followed 401 men for
helped to promote trust in the study. Interaction with partici- 12 months, with one screening visit and five study visits. Most
pants and recruiters further offered the opportunity to obtain prior longitudinal studies of MSM cohorts in SSA were con-
feedback about the study, and to address concerns and miscon- ducted at a single site or in a single country, enrolled open
ceptions (e.g. the misconception that blood draws were used cohorts, or were associated with ongoing clinical care rather
for commercial purposes). Intense mobility in the study popula- than research [33,34].
tion made it hard to reach some participants, despite frequently The legal status and social marginalization experienced by
updating of locator information. In addition, some participants MSM/TGW in SSA has prompted questions about the feasibil-
did not have phones, and some lost their phones during the ity of engaging them in research. The HPTN 075 study had
study. A few participants did not have a street address; this high rates of participant accrual across four sites through a
required creation of maps to collect locator information, making mix of direct and indirect recruitment approaches, including
it harder to locate these participants. Staff reported that some peer outreach, participant and key informant referral, and
participants provided incorrect locator information because venue-based recruitment combined with findings from prior
they had not yet disclosed their sexual orientation to their cross-sectional studies of MSM in SSA [35]. This indicates that
family. Others had concerns that coming to the study site or it is possible to address recruitment and enrolment challenges
being seen with other participants might disclose their sexual in this population.
orientation. School and work obligations made it hard for some The HPTN 075 study had high rates of participant reten-
participants to meet all appointment times. tion over one year at four sites in three countries, averaging

64
 Table 3. Factors associated with loss to follow-up during study, HPTN 075 study, Kenya, Malawi, South Africaa

Univariate Multivariableb
Mean (SD) / n/N (%)
Completed all visits (N = 341) Did not complete the study (N = 28) OR 95% CI p value AOR 95% CI p value

Countryc
Kisumu, Kenya 90/94 (95.7%) 4/94 (4.3%) REF REF
Blantyre, Malawi 84/98 (85.7%) 14/98 (14.3%) 3.73 1.11, 16.17 0.030 3.77 1.12, 16.39 0.029
Cape Town, South Africa 74/84 (88.1%) 10/84 (11.9%) 3.02 0.83, 13.75 0.105 3.29 0.89, 15.09 0.079
Soweto, South Africa 93/93 (100.0%) 0/93 (0.0%) 0.19 0.00, 1.11 0.124 0.22 0.00, 1.32 0.172
HIV status at screening
Negative 281/304 (92.4%) 23/304 (7.6%) REF
Positive 59/64 (92.2%) 5/64 (7.8%) 1.04 0.38, 2.83 0.946
Age 24.30 (5.50) 25.26 (6.36) 1.03 0.97, 1.10 0.386
Education
Low (less than grade 12) 121/132 (91.7%) 11/132 (8.3%) REF
Middle (at least grade 12) 144/153 (94.1%) 9/153 (5.9%) 0.69 0.28, 1.71 0.421
High (beyond secondary school) 71/79 (89.9%) 8/79 (10.1%) 1.24 0.48, 3.23 0.660
Employment status
Full or part time employed 102/110 (92.7%) 8/110 (7.3%) REF
Sandfort TGM et al. Journal of the International AIDS Society 2020, 23(S6):e25600

Self-employed 45/52 (86.5%) 7/52 (13.5%) 1.98 0.68, 5.80 0.211

Unemployed (including in-between jobs) 96/100 (96.0%) 4/100 (4.0%) 0.53 0.15, 1.82 0.314
Student 86/95 (90.5%) 9/95 (9.5%) 1.33 0.49, 3.61 0.570
http://onlinelibrary.wiley.com/doi/10.1002/jia2.25600/full | https://doi.org/10.1002/jia2.25600

Other 10/10 (100.0%) 0/10 (0.0%) N.A.

Marital status
Single/divorced/widowed 318/342 (93.0%) 24/342 (7.0%) REF
Married/civil union/legal partnership 21/25 (84.0%) 4/25 (16.0%) 2.52 0.80, 7.95 0.113
Any children
No 268/285 (94.0%) 17/285 (6.0%) REF REF
Yes 71/82 (86.6%) 11/82 (13.4%) 2.44 1.10, 5.45 0.029 2.05 0.87, 5.05 0.139
Transgender
No 266/289 (92.0%) 23/289 (8.0%) REF
Yes 69/74 (93.2%) 5/74 (6.8%) 0.84 0.31, 2.28 0.730
Sexual attraction
Men and women 183/200 (91.5%) 17/200 (8.5%) REF
Men only 155/166 (93.4%) 11/166 (6.6%) 0.76 0.35, 1.68 0.503
Sexual identity
Bisexual and other 133/144 (92.4%) 11/144 (7.6%) REF
Gay 206/223 (92.4%) 17/223 (7.6%) 1.00 0.45, 2.20 0.996
Negative feelings of homosexuality 1.98 (0.54) 1.92 (0.58) 0.79 0.39, 1.59 0.503
MSM-related stigma in healthcare 1.84 (0.22) 1.92 (0.20) 9.65 0.84, 111.0 0.069
Concealing same-sex sexuality 2.16 (1.18) 1.78 (1.16) 0.74 0.52, 1.07 0.113 0.86 0.55, 1.34 0.496

65
Sandfort TGM et al. Journal of the International AIDS Society 2020, 23(S6):e25600
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p value

AOR, adjusted odds ratio; CI, confidence intervals; MSM, men who have sex with men; n, number with characteristic; N, total number; OR, odds ratio; REF, reference group; SD, standard devia-
92.9%. The high retention was likely driven by the strong

Five participants who died during the study were excluded from this table; Three variables were selected using stepwise model with selection of variables at entry significance level of 0.3 and
commitment and motivation to the study reported by partici-
pants. Study retention may also have been enhanced by the
Multivariableb

novelty of the study and the sense of validation of one’s

same-sex attraction. The relatively high level of education of
95% CI

the participants in HPTN 075 compared to other studies

among MSM in SSA (e.g. [33]) might have facilitated participa-

exit significance level of 0.35; exact logistic regression analysis is applied due to the zero frequency of participants in the study site Soweto who did not complete the study.
tion, even though level of education was not associated with
completion of study visits. Participants reported an interest in
AOR

giving back to their communities through study participation,

in addition to receiving key services, including HIV testing and
risk reduction counselling; this likely reinforced study partici-
p value

0.264
0.454
0.658
0.942
0.470
0.775

pation. The involvement of outreach workers is likely to have

facilitated retention. Findings from HPTN 075 further high-
light the importance of extensive community and site prepara-
Univariate

tion (amongst others for the delivery of culturally appropriate

0.23, 1.49
0.63, 2.81
0.27, 2.28
0.52, 2.03
0.36, 1.60
0.40, 1.99
95% CI

treatment), active involvement of the community and intense

study retention activities. Barriers to retention were limited
and were largely related to mobility of participants.
A very important finding in HPTN 075 was that there were
very few documented social harms that triggered significant
0.59
1.33
0.79
1.03
0.76
0.89
OR

risk mitigation procedures. Given the small number of docu-

mented social harms, preparing RMPs might seem superflu-
Did not complete the study (N = 28)

ous. Alternatively, one could argue that preparation of the

RMPs may have reduced the potential for social harms; this
was suggested by retrospective discussions with research
staff. Without RMPs, staff might have been caught off-guard
1.22 (0.42)
1.28 (0.54)
1.10 (0.32)
1.92 (0.54)
1.82 (0.54)
1.78 (0.50)

and unprepared, which could have aggravated the social harms

that occurred. The few social harms that were observed were
related to consent procedures and staff training and supervi-
sion; future studies should attend closely to these factors.
Some limitations should be considered when evaluating the
findings. Because of the study design, it is not possible to
state with certainty which factors contributed most to the
study’s success. The design also did not allow us to evaluate
the efficiency of the various recruitment strategies. Even
though the study samples collected at each site were diverse,
Completed all visits (N = 341)

they are not necessarily representative of the respective pop-

Mean (SD) / n/N (%)

ulations. Finally, this study was implemented from 2015 to

2017, and although the social situation for sexual minority
1.32 (0.46)
1.22 (0.46)
1.14 (0.42)
1.92 (0.56)
1.90 (0.52)
1.82 (0.48)

persons in SSA is not stable, it is extremely likely that what

was done to make the study successful is still relevant in the
current situation. It is not clear whether COVID-19 would
have an impact on the feasibility of recruitment and retention
specific to MSM and TGW.
The results of this study open the door to further large-
scale HIV prevention research with MSM and TGW in SSA.
Research is needed to improve understanding of the risks and
Importance of study for MSM community
How committed they felt to participating

resiliencies of this key population with respect to HIV trans-

Likelihood to remain in study for a year

mission, and to develop evidence-based approaches to meet

their urgent HIV prevention needs. MSM and TGW in SSA
c

have previously indicated interest in HIV prevention strate-

gies, including condom use and PrEP [36,37]. The results of
HPTN 075 support the conduct of future trials to advance
Setting up appointment

integrated behavioural and biomedical HIV prevention in these

Making time for visit
Table 3. (Continued)

Travel to study site

key populations. MSM and TGW in SSA could benefit from

inclusion in the next generation of HIV prevention trials to
determine whether promising interventions are feasible and
effective for this key population, and to facilitate future imple-
mentation of HIV prevention interventions in these popula-
tion.

tions in SSA.
a

66
 Table 4. Factors associated with missing one or more study visits, HPTN 075 study, Kenya, Malawi, South Africaa

Mean (SD) / n/N (%) Univariate Multivariableb

Completed all visits (N = 341) Missed ≥ 1 visits (N = 27) OR 95% CI p value AOR 95% CI p value

Country
Kisumu, Kenya 90/93 (96.8%) 3/93 (3.2%) REF
Blantyre, Malawi 84/86 (97.7%) 2/86 (2.3%) 0.71 0.12, 4.38 0.716
Cape Town, South Africa 74/89 (83.1%) 15/89 (16.9%) 6.08 1.70, 21.81 0.006
Soweto, South Africa 93/100 (93.0%) 7/100 (7.0%) 2.26 0.57, 9.00 0.248
HIV status at screening
Negative 281/302 (93.0%) 21/302 (7.0%) REF
Positive 59/65 (90.8%) 6/65 (9.2%) 1.36 0.53, 3.52 0.524
Age 24.30 (5.50) 21.82 (3.36) 0.88 0.79, 0.98 0.024
Education
Low (less than grade 12) 121/129 (93.8%) 8/129 (6.2%) REF
Middle (at least grade 12) 144/157 (91.7%) 13/157 (8.3%) 1.37 0.55, 3.40 0.504
High (beyond secondary school) 71/76 (93.4%) 5/76 (6.6%) 1.07 0.34, 3.38 0.915
Employment status
Full or part time employed 102/110 (92.7%) 8/110 (7.3%) REF
Sandfort TGM et al. Journal of the International AIDS Society 2020, 23(S6):e25600

Self-employed 45/47 (95.7%) 2/47 (4.3%) 0.57 0.12, 2.78 0.483

Unemployed (including in-between jobs) 96/104 (92.3%) 8/104 (7.7%) 1.06 0.38, 2.94 0.907
Student 86/93 (92.5%) 7/93 (7.5%) 1.04 0.36, 2.98 0.945
http://onlinelibrary.wiley.com/doi/10.1002/jia2.25600/full | https://doi.org/10.1002/jia2.25600

Other 10/12 (83.3%) 2/30 (16.7%) 2.55 0.48, 13.68 0.275

Marital status
Single/divorced/widowed 318/344 (92.4%) 26/344 (7.6%) REF
Married/civil union/legal partnership 21/22 (95.5%) 1/22 (4.5%) 0.58 0.08, 4.50 0.604
Any children
No 268/292 (91.8%) 24/292 (8.2%) REF
Yes 71/74 (95.9%) 3/74 (4.1%) 0.47 0.14, 1.61 0.231
Transgender
No 266/289 (92.0%) 23/289 (8.0%) REF
Yes 69/73 (94.5%) 4/73 (5.5%) 0.67 0.22, 2.00 0.474
Sexual attraction
Men and women 183/191 (95.8%) 8/191 (4.2%) REF
Men only 155/173 (89.6%) 18/173 (10.4%) 2.66 1.12, 6.28 0.026
Sexual identity
Bisexual and other 133/137 (97.1%) 4/137 (2.9%) REF REF
Gay 206/229 (90.0%) 23/229 (10.0%) 3.71 1.26, 10.97 0.018 4.65 1.29, 16.83 0.019
Negative feelings of homosexuality 1.98 (0.54) 2.04 (0.62) 1.19 0.58, 2.46 0.637 1.91 0.80, 4.53 0.144
MSM-related stigma in healthcare 1.84 (0.22) 1.78 (0.24) 0.31 0.06, 1.49 0.143 0.39 0.07, 2.23 0.288
Concealing same-sex sexuality 2.16 (1.18) 2.66 (1.26) 1.42 1.01, 1.99 0.045 1.29 0.87, 1.90 0.206

67
Sandfort TGM et al. Journal of the International AIDS Society 2020, 23(S6):e25600
http://onlinelibrary.wiley.com/doi/10.1002/jia2.25600/full | https://doi.org/10.1002/jia2.25600

5 | CONCLUSIONS

Five participants who died during the study were excluded from this table; four variables were selected using stepwise model with selection of variables at entry significance level of 0.3 and
AOR, adjusted odds ratio; CI, confidence intervals; MSM, men who have sex with men; n, number with characteristic; N, total number; OR, odds ratio; REF, reference group; SD, standard devia-
p value Enrolling and retaining MSM and TGW in SSA in a multi-coun-
try, longitudinal, biobehavioural cohort study is feasible and
Multivariableb

can be conducted safely and successfully. This is especially the

95% CI

case when the local community of MSM and TGW as well as

the community more generally are involved in the preparation
of the study, and when MSM and TGW play a role in the
actual study implementation. Extensive study site preparation
seems indispensable. The primary barrier to study participa-
AOR

tion is the mobility of participants. Retention can be promoted

in a variety of ways, including by providing needed services
and validation of participants’ sexual minority status. These
p value

findings strongly suggest that needed prevention trials with

0.826
0.131
0.703
0.962
0.756
0.979

MSM and TGW in SSA are viable.

AUTHORS’ AFFILIATIONS
Univariate

1
0.39, 2.14
0.08, 1.38
0.29, 2.32
0.50, 2.05
0.52, 2.44
0.44, 2.32

HIV Center for Clinical and Behavioral Studies, New York State Psychiatric
95% CI

Institute and Columbia University, New York, NY, USA; 2Science Facilitation
Department, FHI 360, Durham, NC, USA; 3Perinatal HIV Research Unit, Univer-
sity of the Witwatersrand, Soweto HPTN CRS, Soweto, South Africa; 4Vaccine
and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seat-
tle, WA, USA; 5Berman Institute of Bioethics, Johns Hopkins University, Balti-
more, MD, USA; 6Department of Pathology, Johns Hopkins University School of
0.91
0.34
0.82
1.02
1.13
1.01
OR

Medicine, Baltimore, MD, USA; 7Department of Epidemiology, Johns Hopkins

Bloomberg School of Public Health, Blantyre, Malawi; 8Desmond Tutu HIV Cen-
tre, UCT Medical School, Cape Town, South Africa; 9Kenya Medical Research
Missed ≥ 1 visits (N = 27)

Institute (KEMRI) CDC, Kisumu, Kenya; 10Anova Health Institute, Johannesburg,

South Africa; 11Centre for the Development of People (CEDEP), Blantyre,
Malawi; 12Division of AIDS Research, National Institute of Mental Health,
1.30 (0.46)
1.08 (0.26)
1.12 (0.42)
1.92 (0.48)
1.92 (0.54)
1.82 (0.48)

Bethesda, MD, USA; 13Division of AID, National Institute of Allergy and Infec-
tious Disease, National Institutes of Health, Bethesda, MD, USA; 14FHI 360,
Durham, NC, USA

COMPETING INTERESTS
Mean (SD) / n/N (%)

Jeremy Sugarman is a member of Merck KGaA’s Bioethics Advisory Panel and

Stem Cell Research Oversight Committee, IQVIA’s Ethics Advisory Panel and
Aspen Neuroscience’s Scientific Advisory Board; he has consulted for Biogen
and Portola Pharmaceuticals Inc. None of these relationships are related to the
Completed all visits (N = 341)

material discussed in this manuscript. None of the other authors has a conflict
of interest or a potential conflict of interest to report.
1.32 (0.46)
1.22 (0.46)
1.14 (0.42)
1.92 (0.56)
1.90 (0.52)
1.82 (0.48)

AUTHORS’ CONTRIBUTIONS
TS, EH, YC, VC, JS, SD, KD, RP, DS, FZ, DR, OR, CM, DK, BK, AO, MS, WC, JL,
MF, LM and SE involved in study design and implementation. AM, XG and YC
analysed the data. TS, EH and SE wrote the manuscript. EH, AM, XG, VC, JS, SD,
KD, DS, MS, WC, JL, YC, MF and LM reviewed manuscript and offered comments
and revisions. All authors have read and approved the final manuscript.

ACKNOWLEDGEMENTS
The authors thank the local community advisory boards, study staff and study
Importance of study for MSM community
How committed they felt to participating

participants. The protocol team included the following members (in addition to
Likelihood to remain in study for a year

authors of the current manuscript): Stefan D Baral, Linda-Gail Bekker, Vanessa

Elharrar, Lynda Emel, Chris(tie) Heiberg, Noel Kayange, Josh Kikuvi, Tim Lane,
Lebah Lugalia, Yamikani Mbilizi, Ernest Moseki, Scott Rose, Paul Semugoma, Jer-
ome Singh, Patrick S Sullivan and Carlos Toledo. Mark Barnes assisted in the
exit significance level of 0.35.

preparation of the risk management plans.

Setting up appointment

FUNDING
Making time for visit
Table 4. (Continued)

Travel to study site

Research reported in this publication was supported by the National Institute of

Allergy and Infectious Diseases and the National Institute of Mental Health of
the National Institutes of Health under award number UM1AI068619 (HPTN
Leadership and Operations Center), UM1AI068617 (HPTN Statistical and Data
Management Center) and UM1AI068613 (HPTN Laboratory Center). The con-
tent is solely the responsibility of the authors and does not necessarily repre-
tion.

sent the official views of the National Institute of Allergy and Infectious
a

68
Sandfort TGM et al. Journal of the International AIDS Society 2020, 23(S6):e25600
http://onlinelibrary.wiley.com/doi/10.1002/jia2.25600/full | https://doi.org/10.1002/jia2.25600

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publish or preparation of the manuscript. 22. Crowell TA, Keshinro B, Baral SD, Schwartz SR, Stahlman S, Nowak RG,
et al. Stigma, access to healthcare, and HIV risks among men who sell sex to
men in Nigeria. J Int AIDS Soc. 2017;20:21489.
23. Duby Z, Nkosi B, Scheibe A, Brown B, Bekker LG. ’Scared of going to the
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people in sub-Saharan, Africa. New York: International Gay and Lesbian Human version of this article:
Rights Commission; 2011. Appendix S1. HPTN 075 site-specific risk mitigation plans.

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