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Eswatini Ring Study: Increasing PrEP Options for Women

Sponsor
FHI 360 (Other)
Overall Status
Recruiting
CT.gov ID
NCT05889533
Collaborator
United States Agency for International Development (USAID) (U.S. Fed)
1,000
Enrollment
8
Locations
19.8
Anticipated Duration (Months)
125
Patients Per Site
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Increasing PrEP Options for Women in Eswatini: A Prospective Mixed Methods Study on the Introduction of the PrEP Vaginal Ring
    Actual Study Start Date :
    May 9, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Other Outcome Measures

    1. Describe clinically relevant indicators among PrEP users, including rates of seroconversion and drug resistance among PEP users who acquire HIV following PrEP initiation. [18 months]

      Proportion and rates of HIV infection among participants; proportion and rates of HIV drug resistance (DR) mutations among PrEP users who acquire HIV.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • HIV negative, 18 or older, not known to be pregnant or breastfeeding, and female at birth.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dvokolwako Health Centre Dvokolwako Swaziland
    2 Manzini KP Community Centre Manzini Swaziland
    3 Matsapha Mobile Clinic Matsapha Swaziland
    4 Mbabane Key Population (KP) Community Centre Mbabane Swaziland
    5 Mbabane Public Health Unit Mbabane Swaziland
    6 Motshane Clinic Mbabane Swaziland
    7 Siphofaneni Inkhundla (DREAMS Outreach) Siphofaneni Swaziland
    8 New Haven Clinic Velebantfu Swaziland

    Sponsors and Collaborators

    • FHI 360
    • United States Agency for International Development (USAID)

    Investigators

    • Principal Investigator: Anita Hettema, MPH, FHI 360
    • Principal Investigator: Sindy Matse, MPH, Ministry of Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    FHI 360
    ClinicalTrials.gov Identifier:
    NCT05889533
    Other Study ID Numbers:
    • FHI 360
    First Posted:
    Jun 5, 2023
    Last Update Posted:
    Jun 7, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by FHI 360
    HIV prevention
    PrEP
    AGYW
    PrEP Ring
    Eswatini

    Study Results

    No Results Posted as of Jun 7, 2023