Same-Day PrEP Initiation and Sexual Health for Transgender Women

NCT04491422 | Completed DMC

• 1 other identifier: REC REF 0105-2020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Transgender women (trans women; assigned male sex at birth but identify as female) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Trans women have a 13 times greater risk of acquiring HIV than adults aged 15-49 years in the general population, and in Africa, trans women have nearly twice the HIV prevalence (25%) of men who have sex with men \[MSM\] (14%). Oral pre-exposure prophylaxis (PrEP) is an effective prevention tool that could change the trajectory of the HIV epidemic among the 25 million trans women globally, yet its use has been suboptimal in this vulnerable population. Same-day PrEP initiation is feasible and acceptable and improves retention in PrEP care in resource-rich settings. Same-day initiation of emtricitabine/tenofovir alafenamide (F/TAF), a new PrEP regimen, has not to our knowledge previously been evaluated as PrEP in African trans women. F/TAF is potentially more efficacious and safer than emtricitabine/tenofovir disoproxil fumarate (F/TDF) as shown in the recent DISCOVER trial. However, concerns about drug-drug interactions between feminizing hormonal therapy (FHT) and PrEP are a key potential adherence barrier for trans women. While PrEP drugs do not lower FHT levels, FHT decreases plasma TFV and (emtricitabine) FTC levels. Little is known about FHT use among African trans women taking F/TAF or how concerns about F/TAF-FHT interactions may influence PrEP adherence. Moreover, interventions to support PrEP adherence in this population are needed. Feedback about PrEP use has been shown to potentially improve PrEP adherence among MSM but has not been utilized among trans women. Key knowledge gaps include: 1) whether same-day PrEP can be successfully implemented for African trans women, 2) the impact of drug-level feedback on PrEP adherence, and 3) how use of FHT may influence PrEP adherence. To address these questions, this protocol describes a randomized trial to evaluate the feasibility and acceptability of same day initiation of F/TAF PrEP, evaluate impact of drug-level feedback on PrEP adherence and characterize PrEP persistence, and in-depth interviews to explore how self-care interventions for sexual health influence prevention choices among trans women and their sexual partners. This will be the first clinical trial, to our knowledge, to evaluate F/TAF as PrEP for HIV-negative trans women in sub-Saharan Africa.

Conditions

HIV; PrEP; Transgender Women; Sexually Transmitted Diseases, Bacterial

Outcome Measures

Primary Outcomes (5)

• Feasibility of same-day initiation of F/TAF as PrEP as measured by participant engagement until the end of study

  Proportion retained on PrEP at months 3, 6, 9 and 12

  12 months

• Acceptability of peer-delivered combination HIV prevention as measured by the System Usability Scale

  System Usability Scale scores range from 0 to 100; higher scores mean better acceptability

  12 months

• Adoption of same-day PrEP initiation as measured by structured questionnaires

  Proportion initiating same-day PrEP at enrollment

  12 months

• Fidelity to iNSC assessed through audio-recorded drug level feedback counseling sessions

  Proportion of research nurses successfully implementing iNSC

  12 months

• PrEP persistence as measured by intracellular tenofovir diphosphate levels in dried blood spots at months 3, 6, 9, 12

  Proportion with tenofovir diphosphate levels \>900 fmol per punch

  12 months

Secondary Outcomes (2)

• Sexual risk behaviors assessed through structured questionnaires

  12 months

• STI incidence assessed through GeneXpert testing

  12 months

Study Arms (2)

Integrated Next Steps Counseling using poi

ACTIVE COMPARATOR

At quarterly visits, intervention arm participants will receive iNSC Support Level 1 to address PrEP adherence and sexual health needs. Those with urine TFV levels \<1000 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.

Combination Product: Integrated Next Steps Counseling with Real-Time Drug Level Feedback

Standard adherence counseling

NO INTERVENTION

Control arm participants will receive standard adherence counseling.

Interventions

Integrated Next Steps Counseling with Real-Time Drug Level Feedback COMBINATION_PRODUCT

Integrated next steps counseling with real-time drug level feedback using point-of-care urine tenofovir testing at quarterly visits

Integrated Next Steps Counseling using poi

Eligibility Criteria

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

You may qualify if:

• Report male sex assigned at birth but currently identify as female
• 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 unprotected anal intercourse in the past 6 months
• Able and willing to provide written informed consent
• Possess a valid recruitment coupon
• HIV-uninfected based on negative HIV rapid tests at the enrollment visit

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 precludes provision of informed consent
• Not planning to remain in the geographic area for the duration of the study

Sponsors & Collaborators

• Makerere University: lead
• Massachusetts General Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• University of Washington: collaborator

Study Sites (1)

Infectious Diseases Institute Kasangati

Kampala, Uganda

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases, Bacterial

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Mujugira, PhD

  Infectious Diseases Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to either quarterly Integrated Next Steps Counseling (iNSC) using point-of-care (POC) urine tenofovir (TFV) levels \[intervention arm\] or standard adherence counseling without drug level feedback \[control arm\].

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 29, 2020
• Study Start: November 2, 2021
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

UG (1)