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Clinical Trials/NCT04030520
NCT04030520
Completed
N/A

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

University of California, San Francisco1 site in 1 country60 target enrollmentJuly 8, 2019
ConditionsHIV/AIDS

Overview

Phase
N/A
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
University of California, San Francisco
Enrollment
60
Locations
1
Primary Endpoint
Initiation of PrEP
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 8, 2019
End Date
October 31, 2021
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Initiation of PrEP

Time Frame: 6 months

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

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.

Study Sites (1)

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