Improving HIV Prevention Among Adolescent Girls and Young Women (AGYW) in Uganda

NCT05516602 | Completed

• 1 other identifier: RGYM220701
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The purpose of the project is to evaluate a peer support intervention aimed at improving uptake of and adherence to oral PrEP. Main Study Aim: To evaluate a peer support intervention aimed at improving uptake of and adherence to oral pre-exposure prophylaxis (PrEP), and its effect on sexual behavioral and reproductive health outcomes Study Objectives: i. To evaluate the effect of a peer support intervention on uptake of and adherence to oral PrEP among 14-24-year-old AGYW at risk of HIV infection in Kampala, Uganda. ii. To evaluate the effect of the peer support intervention aimed at improving oral PrEP uptake and adherence, on sexual behavior and reproductive health outcomes among AGYW in Kampala, Uganda. Design An individually randomized controlled trial with parallel group design and 1:1 randomization in the intervention and control arms. Population: 14-24-year old AGYW at risk of HIV infection in Kampala. Control arm: Standard health worker counselling during clinic visits. Intervention arm: Standard health worker counselling during clinic visits + peer support groups over the weekend.

Conditions

HIV-1-infection

Keywords

Adolescent Girls and Young Women; Oral PrEP; Peer Support; Uganda

Outcome Measures

Primary Outcomes (3)

• The proportion of enrolled participants who take up oral PrEP after randomization to peer support or the standard

  Number of participants who take up oral PrEP divided by the total number enrolled. PrEP uptake was measured as a participants accepting the offer of oral PrEP and picking their first month's supply from the clinic.

  Measured from enrolment to the end of follow up at 12 months

• The proportion of volunteers who take up oral PrEP and adhere to oral PrEP after randomization to peer support or the standard

  Number of participants who adhere to oral PrEP divided by the total number taking oral PrEP. Adherence was measured using self reports, pill counts and rapid urine tenofovir kits

  3 monthly measurements from enrolment to the end of follow up at 12 months

• Time in days to oral PrEP uptake from the date it is offered after randomization to peer support or the standard.

  Number of days from the date a participant is offered oral PrEP to the date they pick the first month's supply from the clinic.

  Measured from enrolment to the end of follow up at 12 months

Secondary Outcomes (4)

• Total number of sexual partners in the past 3 months in the peer support group compared to the standard

  3 monthly measurements from enrolment to the end of follow up at 12 months

• STI and pregnancy incidence at follow up in the peer support group compared to the standard

  3 monthly measurements from enrolment to the end of follow up at 12 months

• Condom use with total sexual partners in the past 3 months in the peer support groups compared to the control

  3 monthly measurements from enrolment to study end at 12 months

• The proportion of participants who are not using a modern contraceptive at baseline and take up a modern contraceptive method at any time during the study

  3 monthly measurements from enrolment to the end of follow up at 12 months

Study Arms (2)

Peer Support

EXPERIMENTAL

Standard health worker counselling during clinic visits plus peer support over the weekends.

Other: Peer Support

Standard

NO INTERVENTION

Standard health worker counselling during clinic visits.

Interventions

Peer Support OTHER

Peer-led support groups over the weekend will include the following activities: * Peer leader counselling on oral PrEP and HIV risk reduction * Peer leader discussion to dispel myths and misconceptions around oral PrEP * Peer leader sharing of experiences of daily pill taking * Participants sharing experiences of influencers and barriers to oral PrEP uptake and adherence followed by a discussion by group members. * 1-2 role plays per support group session.

Peer Support

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV negative (assessed through rapid blood test)
• Sexually active in the past 3 months
• years
• Hepatitis B negative for those who initiate oral PrEP
• Willing to undergo study procedures

You may not qualify if:

• HIV infection
• Currently taking oral PrEP
• Known allergy to common medications, components of oral PrEP or contraceptives
• Pregnant
• An acute or chronic illness that may affect volunteer participation or achieving study objectives
• A condition or situation that in the opinion of the PI/designee would preclude provision of informed consent, or otherwise interfere with achieving the study objectives

Sponsors & Collaborators

• MRC/UVRI and LSHTM Uganda Research Unit: lead
• Uganda Virus Research Institute (UVRI): collaborator
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

MRC/UVRI and LSHTM

Entebbe, Uganda

Location

Related Publications (36)

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  BACKGROUND

Study Officials

• Yunia Mayanja

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: January 12, 2023
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)