NCT04030520: POPPi

Improving Uptake and Adherence to HIV Prevention Services With Pre-exposure Prophylaxis (PrEP), HIV Self- Testing and Adherence Support for Very High Risk HIV-negative Young Women Aged 15-24 in Kampala, Uganda

Completed NA Results posted Last updated 15 July 2025

What this trial tests

NA trial testing POPPi in HIV/AIDS in 60 participants. Completed in 31 October 2021.

Timeline

8 July 2019

Primary endpoint
31 October 2020

31 October 2021

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	8 July 2019
Primary completion	31 October 2020
Estimated completion	31 October 2021
Sites	1 location across Uganda

Drugs / interventions tested

• POPPi
• Comparison

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

University of California, San Francisco

Who can join

Adults 15 to 24, female only, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Initiation of PrEP Primary · 6 months

Initiation of PrEP using the pharmacy records indicating PrEP received by participants.

Group	Value	95% CI
Intervention	18
Comparison	21

Adherence to PrEP Primary · 12 months

Adherence to PrEP using hair analysis measured by the concentration of antiretroviral drug in strands of hair. The results will be measured per participant using concentration in nanograms/milligrams. The number of participants who showed a positive drug concentration in nanograms/milligrams is reported.

Group	Value	95% CI
Intervention	19
Comparison	18

Sponsor's own description

The main aim is to develop and assess an intervention to enhance initiation and adherence to PrEP among HIV negative young women of high risk (YWHR). The specific aims are (1) To conduct formative research to enhance our understanding of the dynamics of the social and sexual networks, and context of young HIV-uninfected women (aged 15-24) engaged in high risk sexual behavior in Kampala, Uganda (2) Document barriers and opportunities for PrEP uptake and adherence as well as repeat HIV testing by self test; (3) To develop and test a socially and culturally acceptable and feasible prevention intervention on uptake and adherence to PrEP and HIV self-testing for young women at high risk for HIV.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. PrEP uptake and persistence amongst HIV-negative women who exchange sex for money or commodities in Kampala, Uganda: A qualitative inquiry assessing the influence of pregnancy.
   Joshi S, Namuddu C, Kasujja FX, Mirembe M, et al · · 2023 · cited 4× · PMID 37368866 · DOI 10.1371/journal.pgph.0000434