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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: POPPi behavioral intervention
* Behavioral: POPPi behavioral intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP | Behavioral: POPPi behavioral intervention<br>* behavioral intervention with offer of HIV self test<br>|
| Active Comparator: comparison<br>participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP | Behavioral: POPPi behavioral intervention<br>* behavioral intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of PrEP | Initiation of PrEP using the pharmacy records indicating PrEP received by participants | 12 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. | 12 months |