Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04742491 | Pre-Exposure Prophylaxis for Transgender Women in the US and South America | PHASE2 | COMPLETED | 304 | — | — | Mar 26, 2021 | Aug 16, 2024 | Dec 17, 2025 | 5 | United States, Brazil |
Time to PrEP initiation is defined as the duration from enrollment to the PrEP start date.
Self-reported adherence to daily PrEP by study visit
Number of participants accepting co-located GAHT services at baseline and subsequent quarterly study visits.
Participant retention at weeks 26, 52 and 78 by study arm. Retention defined as the number of participants who completed the visit divided by the number of participants who are expected or have completed the visit.
The average number of peer health navigator encounters.
PrEP persistent is defined as the proportion of study visits where a participant demonstrates high adherence to PrEP among those who initiated PrEP at the study clinic. High adherence at a visit is based on drug concentrations in dried blood spots (DBS): Truvada (TDF/FTC): TFV-DP ≥ 900 fmol/punch Descovy (TAF/FTC): TFV-DP ≥ 950 fmol/punch PrEP persistent reflects sustained high PrEP adherence across multiple visits over time, rather than high PrEP adherence at a single point.
| Arm | Type | Description |
|---|---|---|
| Immediate Intervention Arm | EXPERIMENTAL | PrEP (pre-exposure prophylaxis) provision, STI screening and treatment, GAHT (gender-affirming hormonal therapy), peer-health management using strengths-based management. PrEP provision includes using one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil. |
| Deferred Intervention Arm | EXPERIMENTAL | 0-6 months PrEP (pre-exposure prophylaxis) provision and STI screening and treatment. From months 6-18, GAHT (gender-affirming hormonal therapy) and peer-health management using strengths-based management. PrEP provision includes one daily tablet of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25mg, FTC/TAF) or one daily tablet of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in the US, and one daily table of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, FTC/TDF) in Brazil. |
| Name | Type | Description |
|---|---|---|
| Immediate Intervention Arm | DRUG | Truvada, Descovy in the United States; Truvada in Brazil |
| Deferred Intervention Arm | DRUG | Truvada, Descovy in the United States; Truvada in Brazil |
Inclusion Criteria: * TGW (assigned male at birth, trans-feminine spectrum - as defined in the SSP Manual - by self-report) who meet all of the following criteria are eligible for inclusion in this study. * Eighteen years or older at the time of screening. * Willing and able to provide informed con...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Abbott Laboratories | ABT | 1 | PHASE4 | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | PHASE4 | Undisclosed |