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 (POPPi)

University of California San Francisco (UCSF)

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: POPPi; Behavioral: Comparison

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04030520

R34MH114523 (U.S. NIH Grant/Contract)

MH114523

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

intervention

Experimental group

Description:

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

Treatment:

Behavioral: POPPi

comparison

Active Comparator group

Description:

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

Treatment:

Behavioral: Comparison