Clinical Trials

MainTitle

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)

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2019 by University of California, San Francisco

Sponsor
University of California, San Francisco

Collaborator
MRC/UVRI Uganda Research Unit on Aids
Medical Research Council
London School of Hygiene and Tropical Medicine

Information provided by (Responsible Party)
University of California, San Francisco
ClinicalTrials.gov Identifier
NCT04030520

First received: July 8, 2019
Last updated: July 22, 2019
Last Verified: July 2019
History of Changes
Purpose

Purpose

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 Intervention
HIV/AIDS

Behavioral : POPPi behavioral intervention

Study Type: Interventional
Study Design: 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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures

  • Initiation of PrEP [ Time Frame: 12 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.

Estimated Enrollment: 60
Study Start Date: July 8, 2019
Estimated Study Completion Date: August 30, 2020
Estimated Primary Completion Date: July 30, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 15 Years to 24 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04030520

Contacts

Contact:   Rachel King, PhD 7079373280 rachel.king@ucsf.edu
Contact:   Janet Seeley (+256) (0) 417704000 janet.Seeley@mrcuganda.org

Locations

Uganda
Uganda Virus Research Institute Recruiting
Entebbe, Uganda
Contact: Rachel King, PhD

Sponsors and Collaborators

University of California, San Francisco
MRC/UVRI Uganda Research Unit on Aids
Medical Research Council
London School of Hygiene and Tropical Medicine

Investigators

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

More Information


Responsible Party: University of California, San Francisco  
ClinicalTrials.gov Identifier: NCT04030520   History of Changes  
Other Study ID Numbers: MH114523  
Study First Received: July 8, 2019  
Last Updated: July 22, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on August 07, 2020
This information is provided by ClinicalTrials.gov.