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

HIV/AIDS Clinical Trial

— POPPi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030520
• Other study ID #: MH114523
• Secondary ID: R34MH114523
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

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