Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04867798 |
| Other study ID # |
REC REF 1208-2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 16, 2021 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Makerere University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Transgender men (trans men; assigned female sex at birth but identify as male) are generally
thought to be at low risk of HIV acquisition, perhaps because of the assumption that they
have sex with cis-gender women. Emerging data from resource-rich settings show that trans men
often face many of the same high risks as transgender women (trans women; assigned male sex
at birth but identify as female). Trans men report similar rates to trans women of engagement
in sex work and engage in unprotected receptive vaginal and/or anal sex with cis-gender men.
Additionally, they report high sexual risk-taking behaviors including inconsistent condom use
which puts them at risk of HIV and other sexually transmitted infections (STIs). Little is
known about HIV risk in trans men globally, and no published data are available from
sub-Saharan Africa. We will recruit a cohort of 50 trans men through respondent driven
sampling. We will use mixed methods to gain a deeper understanding of the sexual health
experiences and risk behaviors of trans men in Uganda. Guided by the Social Ecological Model,
we will conduct in-depth interviews with up to 20 trans men to understand individual,
interpersonal, community and social contextual factors that influence sexual risk behaviors
and HIV/STI risk (Aim 1). In Aim 2, we will characterize HIV and STI prevalence and risk
among trans men by conducting a behavioral HIV risk assessment including sexual practices,
alcohol and drug use, partner violence, gender dysphoria, male hormone use and willingness to
take PrEP. In Aim 3, we will evaluate PrEP uptake and persistence among HIV-negative trans
men with HIV risk. Participants will be offered PrEP and followed monthly for 12 months. At
quarterly visits, participants will receive integrated next steps adherence counseling and
drug level feedback using a point-of-care urine tenofovir lateral-flow immunoassay. Free
testing and treatment of common curable STIs (Neisseria gonorrhoeae, Chlamydia trachomatis
and Trichomonas vaginalis) will be provided. Primary outcomes are: 1) PrEP persistence at 6
and 12 months as measured by tenofovir levels in dried blood spots collected quarterly, and
2) STI incidence. Assessment of PrEP use by trans men will help increase the utilization of
HIV services, including HIV and STI testing and PrEP, with a goal of decreasing HIV
acquisition.
Description:
Transgender men (trans men; assigned female sex at birth but identify as male) are generally
thought to be at low risk of HIV acquisition, perhaps because of the assumption that they
have sex with cis-gender women. Emerging data from resource-rich settings show that trans men
often face many of the same high risks as transgender women (trans women; assigned male sex
at birth but identify as female). Trans men report similar rates to trans women of engagement
in sex work and engage in unprotected receptive vaginal and/or anal sex with cis-gender men.
Additionally, they report high sexual risk-taking behaviors including inconsistent condom use
which puts them at risk of HIV and other sexually transmitted infections (STIs). Little is
known about HIV risk in trans men globally, and no published data are available from
sub-Saharan Africa. In partnership with the trans community, we are testing the effectiveness
of peer-delivered HIV self-testing, STI self-sampling and pre-exposure prophylaxis (PrEP)
(Peer Study), same-day PrEP initiation and sexual health for trans women in Uganda (Tandika
PrEP Study) and conducting a pilot evaluation of HIV and STI risk in trans men (HASTE study).
This study is designed to leverage the community linkages, collaborative partnerships with
transgender organizations, peer networks, scientific expertise and research infrastructure of
these ongoing studies with trans women and men and proposes a concurrent mixed methods study
(1) to explore HIV and STI risk characteristics, and PrEP adherence among trans men. Thus,
the work extends our unique research experience in the transgender population in Uganda and
this study will be the first, to our knowledge, to characterize HIV and STI risk and PrEP
adherence among trans men in sub-Saharan Africa.
Approach: In Aim 1, we will characterize HIV and STI prevalence and risk in a new cohort of
trans men. In Aim 2, we will evaluate PrEP uptake and persistence among HIV-negative trans
men followed for 12 months. In Aim 3, we will explore the sexual health experiences and risk
behaviours of trans men.
Aim 1: Characterize HIV and STI prevalence and risk among trans men. We will recruit a novel
cohort of up to 50 trans men through the respondent driven sampling (RDS) approaches used in
the above-noted studies. We will conduct a behavioral HIV risk assessment including questions
about gender identity, HIV and STI testing, and willingness to take PrEP.
Interviewer-administered questionnaires will collect data on demographic characteristics, HIV
and STI testing behaviors, perception of risk, alcohol and drug use, sexual practices,
partner violence, gender dysphoria and male hormone use. Primary outcomes will be: 1) HIV
prevalence as measured by the proportion testing HIV positive, 2) STI prevalence as measured
by Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis test positivity and
3) sexual risk behaviours as measured by the proportion reporting condom-less sex.
Aim 2: Evaluate PrEP uptake and persistence among HIV-negative trans men. HIV-negative trans
men will be offered PrEP and followed monthly for 12 months. At quarterly visits,
participants will receive integrated next steps counseling (iNSC) adherence counseling and
drug level feedback using a point-of-care (POC) urine tenofovir lateral-flow immunoassay.
Free testing and treatment of common curable STIs (Neisseria gonorrhoeae, Chlamydia
trachomatis and Trichomonas vaginalis) will be provided. Those who screen positive for
depression will be actively linked to mental health services. Primary outcomes are: 1) PrEP
uptake as measured by pharmacy records and 2) PrEP persistence as measured by intracellular
tenofovir diphosphate concentrations in dried blood spots at months 6 and 12.
Aim 3: Explore sexual health experiences and risk behaviours of trans men in Uganda.
We will use qualitative methods to gain a deeper understanding of the sexual health
experiences of trans men in the context of their everyday lives and communities. Guided by
the Social Ecological Model, we will conduct in-depth interviews with up to 20 trans men to
understand individual, interpersonal, community and social contextual factors that influence
sexual risk behaviors and HIV/STI risk. We will explore unmet HIV/STI prevention needs,
examine perceptions of PrEP and explore barriers and facilitators of retention in HIV care
(stigma, discrimination, and concerns about interactions between hormones and PrEP).
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