Transgender Men and HIV in Uganda: PrEP Uptake and Persistence

NCT04867798 | Completed

• 1 other identifier: REC REF 1208-2020
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Sexually Transmitted Infections; PrEP; Transgender Men

Outcome Measures

Primary Outcomes (1)

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

  Proportion with tenofovir concentrations ≥700 fmol per punch

  12 months

Secondary Outcomes (1)

• Correlates of PrEP adherence as measured by demographic characteristics and sexual behaviors

  12 months

Interventions

Lamivudine-Tenofovir 300 Mg-300 Mg Oral Tablet DRUG

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.

Eligibility Criteria

• Age: 14 Years+
• Gender Eligibility Details: Self-identify as transgender men
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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?

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Infectious Diseases Institute Kasangati

Kampala, Uganda

Location

Related Publications (1)

• 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. 2025 Nov 12. doi: 10.1007/s10461-025-04954-x. Online ahead of print.

  PMID: 41222617 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Mujugira

  Infectious Diseases Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: April 30, 2021
• Study Start: September 16, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)