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HIVNCT04867798

Transgender Men and HIV in Uganda: PrEP Uptake and Persistence

An observational study of HIV and Sexually Transmitted Infections, run by Makerere University at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 14 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
HIV, Sexually Transmitted Infections, PrEP
What is being tested?
Lamivudine-Tenofovir 300 Mg-300 Mg Oral Tablet
Type of treatment
Pill or oral medicine
How many people
75 participants
Where
1 siteUganda
Study dates
16 Sep 2021to 30 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Transgender men (up to 50 participants). Gender identity will be assessed using a two-step approach: 1. What is your current gender? 2. What sex were you assigned at birth?

Who may be able to join

  • Report female sex assigned at birth but currently identify as male
  • Age ≥18, or if 14-17 years, qualification as a mature or emancipated minor due to having a sexually transmitted infection or cater for own livelihood
  • Report condom-less sex in the past 6 months
  • Able and willing to provide written informed consent

Who cannot join

  • Currently enrolled in a biomedical HIV prevention study
  • Any clinically significant or chronic medical condition that is considered progressive or in the opinion of the investigator would make the participant unsuitable for the study, including severe infections requiring treatment such as tuberculosis, alcohol or drug abuse, or mental illness which preclude provision of informed consent. Those with alcohol or drug abuse who are able to independently provide consent will be not be excluded.
  • Not planning to remain in the geographic area for the duration of the study

Trial locations and contacts

1 site in 1 country.

Uganda1 site
  • Infectious Diseases Institute Kasangati

    Kampala

Other trials in Uganda

About this study

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.

Read the detailed 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).

Being tested
Lamivudine-Tenofovir 300 Mg-300 Mg Oral Tablet
Medical subject headings
Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lamivudine-Tenofovir 300 Mg-300 Mg Oral TabletDrug

    PrEP eligible participants will be asked to follow up monthly for 12 months. PrEP will be prescribed for once-daily use and discontinued if HIV tests are positive. At quarterly visits, participants will receive Integrated Next Steps Counseling (iNSC) for PrEP adherence with point-of-care drug level feedback. Participants will receive iNSC Support Level 1 to address PrEP adherence and sexual health needs. Those with urine tenofovir levels <1500 ng/mL will receive iNSC Support Level 2, in which participant responses to two 7-item questionnaires on PrEP adherence and sexual health will guide problem solving on improved dosing. Medication refills will consist of 3-month supplies.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PrEP effectiveness as measured by intracellular tenofovir diphosphate levels in dried blood spots

    Proportion with tenofovir concentrations ≥700 fmol per punch

    Measured: 12 months

Secondary outcomes (1)
  1. Correlates of PrEP adherence as measured by demographic characteristics and sexual behaviors

    Association between HIV risk and PrEP adherence

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start16 Sep 2021
  3. Primary completion30 Apr 2023
  4. Study completion30 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04867798
Sponsor's protocol ID
REC REF 1208-2020
Status last verified
Oct 2023
First submitted
29 Apr 2021
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mujugira A, Kasiita V, Bagaya M, Nsubuga R, Nakyanzi A, Nampewo O, Nalumansi A, Kamusiime B, Bambia F, Muwonge TR, Gandhi M, Ware NC, Haberer JE. Oral PrEP Use by Transgender Men in Uganda: A Multi-method Evaluation. AIDS Behav. 2026 Apr;30(4):1050-1062. doi: 10.1007/s10461-025-04954-x. Epub 2025 Nov 12.

    PubMed 41222617

Questions about this trial

What is this clinical trial studying?

An observational study of HIV and Sexually Transmitted Infections, run by Makerere University at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP effectiveness as measured by intracellular tenofovir diphosphate levels in dried blood spots (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04867798, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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