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

NCT04030520 | Completed Results DMC

• 2 other identifiers: MH114523R34MH114523
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

• Initiation of PrEP

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

  6 months

• Adherence to PrEP

  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.

  12 months

Study Arms (2)

intervention

EXPERIMENTAL

participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP

Behavioral: POPPi

comparison

ACTIVE COMPARATOR

participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP

Behavioral: Comparison

Interventions

POPPi BEHAVIORAL

behavioral intervention with offer of HIV self test

intervention

Comparison BEHAVIORAL

standard of care

comparison

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female age 15- to 24-years old
• Engaging in high-risk sexual behavior having had sex at least once in last three months, --HlV-negative
• Agree to participate in a minimum of four interviews over a 12-month period; including baseline
• Willing to receive services at Good Health for Women Project (GHWP)
• For those initiating PrEP (Truvada):
• Participants should have immunity to Hepatitis B infection and serum creatinine before
• Contra-indications for starting Truvada to be considered include Creatinine \> 1.2 ( (mgldl) or 0.106 (mmolil) and a weight below 35kg.

You may not qualify if:

• Inability to consent to participation in the study
• Condition impeding participation in the study, including severe mental reason to the discretion of the principal investigator, cognitive impairment or illness; serious medical illness or developmental disability and any other reason to the discretion of the principal investigator.

Sponsors & Collaborators

• University of California, San Francisco: lead
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator
• Medical Research Council: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Uganda Virus Research Institute

Entebbe, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr Rachel King
• Organization: University of California San Francisco

rachel.king@ucsf.edu

+256785304516

Study Officials

• Rachel King, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 24, 2019
• Study Start: July 8, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2021
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)