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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04030520
Other study ID # MH114523
Secondary ID R34MH114523
Status Completed
Phase N/A
First received
Last updated
Start date July 8, 2019
Est. completion date October 31, 2021

Study information

Verified date March 2022
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 31, 2021
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 24 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
POPPi behavioral intervention
behavioral intervention with offer of HIV self test
POPPi behavioral intervention
behavioral intervention

Locations

Country Name City State
Uganda Uganda Virus Research Institute Entebbe

Sponsors (5)

Lead Sponsor Collaborator
University of California, San Francisco London School of Hygiene and Tropical Medicine, Medical Research Council, MRC/UVRI and LSHTM Uganda Research Unit, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Initiation of PrEP Initiation of PrEP using the pharmacy records indicating PrEP received by participants 12 months
Primary 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
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