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.
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.
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).
- Conditions
- HIV, Sexually Transmitted Infections, PrEP, Transgender Men
- 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.
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)
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.
- First posted30 Apr 2021
- Study start16 Sep 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Andrew Mujugira, Principal investigator, Infectious Diseases Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transgender Men and HIV in Uganda: PrEP Uptake and Persistence
- ClinicalTrials.gov ID
- NCT04867798
- Acronym / sponsor ID
- REC REF 1208-2020
- Conditions
- HIV, Sexually Transmitted Infections, PrEP, Transgender Men
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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?
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamivudine-Tenofovir 300 Mg-300 Mg Oral TabletPrEP 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. | Drug | – |
Primary outcome
PrEP effectiveness as measured by intracellular tenofovir diphosphate levels in dried blood spots
Time frame: 12 months
Proportion with tenofovir concentrations ≥700 fmol per punch
1 secondary outcome
Correlates of PrEP adherence as measured by demographic characteristics and sexual behaviors
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 41222617Mujugira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Mujugira principal investigator
Infectious Diseases Institute
1 site in 1 country: see every site and its status.
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.