Eswatini Ring Study: Increasing PrEP Options for Women

Last updated: March 13, 2025
Sponsor: FHI 360
Overall Status: Terminated

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05889533
FHI 360
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Study Design

Total Participants: 904
Study Start date:
May 09, 2023
Estimated Completion Date:
January 27, 2025

Study 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.

Connect with a study center

  • Dvokolwako Health Centre

    Dvokolwako,
    Eswatini

    Site Not Available

  • Manzini KP Community Centre

    Manzini,
    Eswatini

    Site Not Available

  • Matsapha Mobile Clinic

    Matsapha,
    Eswatini

    Site Not Available

  • Mbabane Key Population (KP) Community Centre

    Mbabane,
    Eswatini

    Site Not Available

  • Mbabane Public Health Unit

    Mbabane,
    Eswatini

    Site Not Available

  • Motshane Clinic

    Mbabane,
    Eswatini

    Site Not Available

  • Siphofaneni Inkhundla (DREAMS Outreach)

    Siphofaneni,
    Eswatini

    Site Not Available

  • New Haven Clinic

    Velebantfu,
    Eswatini

    Site Not Available

  • Dvokolwako Health Centre

    Dvokolwako,
    Swaziland

    Active - Recruiting

  • Manzini KP Community Centre

    Manzini,
    Swaziland

    Active - Recruiting

  • Matsapha Mobile Clinic

    Matsapha,
    Swaziland

    Active - Recruiting

  • Mbabane Key Population (KP) Community Centre

    Mbabane,
    Swaziland

    Active - Recruiting

  • Mbabane Public Health Unit

    Mbabane,
    Swaziland

    Active - Recruiting

  • Motshane Clinic

    Mbabane,
    Swaziland

    Active - Recruiting

  • Siphofaneni Inkhundla (DREAMS Outreach)

    Siphofaneni,
    Swaziland

    Active - Recruiting

  • New Haven Clinic

    Velebantfu,
    Swaziland

    Active - Recruiting

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