Skip to main content
OpenTrials
Completed

NCT Number: NCT04030520

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

15 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Uganda Virus Research Institute

Entebbe, Uganda

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

POPPi

Behavioral

behavioral intervention with offer of HIV self test

Comparison

Behavioral

standard of care

Primary outcomes

  1. Initiation of PrEP

    Time frame: 6 months

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

  2. Adherence to PrEP

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • MRC/UVRI and LSHTM Uganda Research Unit
  • Medical Research Council
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: POPPi

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 24, 2019
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.