search
Back to results

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 (POPPi)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
POPPi behavioral intervention
POPPi behavioral intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

15 Years - 24 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Uganda Virus Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention

comparison

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 8, 2019
Last Updated
March 21, 2022
Sponsor
University of California, San Francisco
Collaborators
MRC/UVRI and LSHTM Uganda Research Unit, Medical Research Council, London School of Hygiene and Tropical Medicine, National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04030520
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
MRC/UVRI and LSHTM Uganda Research Unit, Medical Research Council, London School of Hygiene and Tropical Medicine, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
participants will receive a behavioral intervention including counseling and offer of HIV oral fluid self test and PrEP
Arm Title
comparison
Arm Type
Active Comparator
Arm Description
participants will be not be offered HIV oral fluid self test but receive counseling, condoms and offered PrEP
Intervention Type
Behavioral
Intervention Name(s)
POPPi behavioral intervention
Intervention Description
behavioral intervention with offer of HIV self test
Intervention Type
Behavioral
Intervention Name(s)
POPPi behavioral intervention
Intervention Description
behavioral intervention
Primary Outcome Measure Information:
Title
Initiation of PrEP
Description
Initiation of PrEP using the pharmacy records indicating PrEP received by participants
Time Frame
12 months
Title
Adherence to PrEP
Description
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.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel King, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uganda Virus Research Institute
City
Entebbe
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs