POPPi: 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

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT04030520

Collaborator

MRC/UVRI and LSHTM Uganda Research Unit (Other), Medical Research Council (Other), London School of Hygiene and Tropical Medicine (Other), National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

27.8

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS	Behavioral: POPPi behavioral intervention Behavioral: POPPi behavioral intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jul 8, 2019

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: intervention

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

Behavioral: POPPi behavioral intervention

behavioral intervention with offer of HIV self test

Active Comparator: comparison

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

Behavioral: POPPi behavioral intervention

behavioral intervention

Outcome Measures

Primary Outcome Measures

Initiation of PrEP [12 months]
Initiation of PrEP using the pharmacy records indicating PrEP received by participants
Adherence to PrEP [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 24 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uganda Virus Research Institute	Entebbe		Uganda

Sponsors and Collaborators

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

Investigators

Principal Investigator: Rachel King, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT04030520

Other Study ID Numbers:

MH114523
R34MH114523

First Posted:

Jul 24, 2019

Last Update Posted:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome

HIV Infections

Study Results

No Results Posted as of Mar 23, 2022