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

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: POPPi behavioral intervention

• Registration Number: NCT04030520
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-08
• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-24
• Primary Completion: 2020-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	POPPi behavioral intervention	participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP
comparison	POPPi behavioral intervention	participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP

Primary Outcome Measures

Name	Time	Method
Initiation of PrEP	12 months	Initiation of PrEP using the pharmacy records indicating PrEP received by participants
Adherence to PrEP	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.

Trial Locations

Locations (1)

Uganda Virus Research Institute; 🇺🇬 Entebbe, Uganda