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Drug-Level Feedback Fails to Boost PrEP Adherence in Ugandan Transgender WomenCounseling and Drug Feedback Show No Change in PrEP Adherence

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Key Takeaway
Drug-level feedback did not improve PrEP adherence in Ugandan transgender women; long-acting options may be needed.

This randomized controlled trial evaluated whether drug-level feedback combined with tailored adherence counseling could improve PrEP adherence among 200 HIV-negative transgender women in Uganda. Participants were followed for 12 months, with adherence assessed through tenofovir levels in dried blood spots and urine.

Same-day initiation of emtricitabine/tenofovir alafenamide (F/TAF) was achieved in 100% of participants. In the intervention arm, urine tenofovir detection was 79%, 80%, 85%, and 70% at 3, 6, 9, and 12 months, respectively. Dried blood spot tenofovir detection was lower, at 46%, 40%, 35%, and 31% over the same periods. Median tenofovir DBS concentrations were 40.6 fmol/punch in the intervention arm and 47.0 fmol/punch in the standard-of-care arm.

The primary adherence outcome showed no intervention effect (adjusted incidence rate ratio [aIRR] 1.06; 95% CI 0.82–1.37). Factors positively associated with adherence included never being harassed by police (aIRR 1.66; 95% CI 1.24–2.23), a history of taking daily medication for more than 7 days (aIRR 1.51; 95% CI 1.18–1.93), and higher monthly income (aIRR 1.44; 95% CI 1.10–2.04).

Overall PrEP adherence was low, which limits the study's ability to detect an intervention effect. No safety data were reported. The authors suggest that long-acting injectable PrEP should be considered for this population, though this remains a recommendation rather than a proven strategy from this trial.

How this fits prior evidence

How this fits prior evidence: This study addresses a gap in understanding the efficacy of behavioral interventions for PrEP adherence in specific populations. While previous evidence noted that F/TAF PrEP showed similar HIV incidence to F/TDF in cisgender women but did not prove noninferiority due to low adherence, this study specifically examines whether tailored counseling can improve that adherence in transgender women. The results indicate that drug-level feedback did not improve adherence in this cohort.

Researchers conducted a randomized controlled trial in Uganda to see if specific support methods could improve PrEP adherence. The study included 200 HIV-negative transgender women. One group received drug-level feedback and tailored counseling, while the other group received standard care. The study tracked medication levels in urine and blood spots over 12 months.

The results showed that while the counseling and feedback were feasible, they did not actually improve the rate of PrEP adherence compared to standard care. However, researchers did find that other factors, such as higher monthly income, a history of taking daily medication, and not being harassed by police, were linked to better adherence.

Because the study found no significant improvement from the specific counseling intervention, it suggests that other factors may play a larger role in how well patients stay on their medication. Patients should talk to their healthcare providers to discuss the best ways to manage their specific treatment plans.

What this means for you:
Counseling and drug-level feedback did not improve PrEP adherence in this study of transgender women.

Common questions

Did the counseling and feedback help people stay on their medication?

No, the study found that the intervention of drug-level feedback and tailored counseling did not have a significant effect on PrEP adherence compared to standard care. While the program was feasible, it did not change the rate of adherence for the participants in the study.

What factors were linked to better medication adherence?

The study found that higher monthly income, a history of taking daily medication for more than 7 days, and never being harassed by police were all associated with better PrEP adherence. These factors showed a positive link to staying on medication.

Was the program safe for the participants?

The study did not report any specific adverse events, serious adverse events, or reasons for discontinuation. However, the study noted that overall PrEP adherence remained low across the group.

Study Details

Study typeRct
Sample sizen = 200
EvidenceLevel 2
Follow-up12.0 mo
PublishedOct 2026
View Original Abstract ↓
OBJECTIVE: To evaluate the feasibility and acceptability of same-day initiation of emtricitabine/tenofovir alafenamide (F/TAF) pre-exposure prophylaxis (PrEP) and test the impact of drug-level feedback on PrEP adherence among transgender women (TGW) in Uganda. DESIGN: Randomized controlled trial. METHODS: HIV-negative TGW were randomly assigned 1 : 1 to intervention (drug-level feedback with tailored adherence counseling) or standard-of-care (SOC), and followed quarterly for 12 months (November 2021-July 2023; NCT04491422). Quarterly clinic visits included demographic and socio-behavioral data collection, PrEP refills, STI testing, and quarterly PrEP adherence assessment using tenofovir levels in dried blood spots (DBS; long-term) and urine (short-term). RESULTS: We enrolled 200 TGW (100 per arm), median age 21 years. Same-day F/TAF PrEP initiation was 100%. Tenofovir detection in urine (intervention arm) was 79, 80, 85, and 70% at the 3, 6, 9, and 12-month visits, respectively. Tenofovir detection in DBS was 46, 40, 35, and 31% at 3, 6, 9, and 12 months, respectively. Median tenofovir DBS concentrations were 40.6 and 47.0 fmol/punch in intervention and SOC arms, respectively. There was no intervention effect on PrEP adherence (DBS tenofovir levels) [adjusted incidence rate ratio (aIRR) 1.06; 95% CI: 0.82-1.37]. Never being harassed by police for being transgender (aIRR 1.66; 95% CI: 1.24-2.23), history of taking daily medication for more than 7 days (aIRR 1.51; 95% CI: 1.18-1.93) and higher monthly income (aIRR 1.44; 95% CI: 1.10-2.04) were associated with PrEP adherence. CONCLUSION: Oral F/TAF PrEP adherence among TGW in Uganda was low and not affected by drug-level feedback or tailored adherence counseling. Long-acting injectable PrEP formulations should be considered for this population.
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