Eswatini Ring Study: Increasing PrEP Options for Women

Terminated

• Conditions: HIV Prevention

• Registration Number: NCT05889533
• Lead Sponsor: FHI 360

Brief Summary

The study will deliver PrEP choice between oral PrEP and the PrEP ring for women in PEPFAR/USAID public health service delivery sites, building on the existing PrEP service delivery models at each site and in accordance with national guidelines for PrEP service delivery in Eswatini. The overall goal of the study is to characterize and assess the feasibility, acceptability, uptake, patterns of use, and clinical outcomes of an enhanced service delivery package providing fully informed choice of oral PrEP and the PrEP ring among women, especially adolescent girls and young women, in Eswatini.

Detailed Description

The study will deliver PrEP choice between oral PrEP and the PrEP ring for women in PEPFAR/USAID public health service delivery sites, building on the existing PrEP service delivery models at each site and in accordance with national guidelines for PrEP service delivery in Eswatini. The overall goal of the study is to characterize and assess the feasibility, acceptability, uptake, patterns of use, and clinical outcomes of an enhanced service delivery package providing fully informed choice of oral PrEP and the PrEP ring among women, especially adolescent girls and young women, in Eswatini.

The two main study components include the following:

1. Prospective, observational cohort of eligible individuals interested in initiating PrEP or continuing PrEP with screening for entry at time of HIV testing and followed throughout the study period (up to 18 months). Data collection will involve quantitative methods and for a subset of participants, data will also be collected using qualitative means, namely in-depth interviews, and focus group discussions.

2. Mixed methods process evaluation that will document implementation of the enhanced service delivery package, assess ongoing perceptions of service delivery (i.e., acceptability and feasibility, barriers and facilitators) among providers and end users, and document other important implementation considerations including the integration of PrEP and family planning.

Study Timeline

• Study Start: 2023-05-09
• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-05
• Primary Completion: 2025-01-27
• Study Completion: 2025-01-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 904

Inclusion Criteria

• HIV negative, 18 or older, not known to be pregnant or breastfeeding, and female at birth.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterize implementation of the service delivery package for informed PrEP choice for women	18 months	Health system feasibility and delivery acceptance among users/providers

Secondary Outcome Measures

Name	Time	Method
Describe patterns of PrEP use in the context of informed PrEP choice	18 months	Overall and method-specific PrEP uptake; continuation/switching/discontinuation of PrEP products; product acceptability among users.

Trial Locations

Locations (8)

Siphofaneni Inkhundla (DREAMS Outreach); 🇸🇿 Siphofaneni, Eswatini

New Haven Clinic; 🇸🇿 Velebantfu, Eswatini

Dvokolwako Health Centre; 🇸🇿 Dvokolwako, Eswatini

Manzini KP Community Centre; 🇸🇿 Manzini, Eswatini

Matsapha Mobile Clinic; 🇸🇿 Matsapha, Eswatini

Mbabane Key Population (KP) Community Centre; 🇸🇿 Mbabane, Eswatini

Mbabane Public Health Unit; 🇸🇿 Mbabane, Eswatini

Motshane Clinic; 🇸🇿 Mbabane, Eswatini