Eswatini Ring Study: Increasing PrEP Options for Women

January 8, 2024 updated by: FHI 360

Increasing PrEP Options for Women in Eswatini: A Prospective Mixed Methods Study on the Introduction of the PrEP Vaginal Ring

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Swaziland
      • Dvokolwako, Swaziland
        • Recruiting
        • Dvokolwako Health Centre
        • Contact:
      • Manzini, Swaziland
        • Recruiting
        • Manzini KP Community Centre
        • Contact:
      • Matsapha, Swaziland
        • Recruiting
        • Matsapha Mobile Clinic
        • Contact:
      • Mbabane, Swaziland
        • Recruiting
        • Mbabane Key Population (KP) Community Centre
        • Contact:
      • Mbabane, Swaziland
        • Recruiting
        • Mbabane Public Health Unit
        • Contact:
      • Mbabane, Swaziland
        • Recruiting
        • Motshane Clinic
        • Contact:
      • Siphofaneni, Swaziland
        • Recruiting
        • Siphofaneni Inkhundla (DREAMS Outreach)
        • Contact:
      • Velebantfu, Swaziland
        • Recruiting
        • New Haven Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Those meeting eligibility criteria seeking PrEP services at study sites.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterize implementation of the service delivery package for informed PrEP choice for women
Time Frame: 18 months
Health system feasibility and delivery acceptance among users/providers
18 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe clinically relevant indicators among PrEP users, including rates of seroconversion and drug resistance among PEP users who acquire HIV following PrEP initiation.
Time Frame: 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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FHI 360

Collaborators

United States Agency for International Development (USAID)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FHI 360

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with the USAID Automated Directives System 579, after acceptance of any knowledge product presenting study findings and after being cleaned of any information that could be used to personally identify participants, the quantitative survey dataset along with relevant documentation will be registered with USAID's Development Data Library (DDL) and made available publicly in an open data repository, to the extent permissible by Eswatini's data privacy and data sharing regulations.

IPD Sharing Time Frame

After study completion and manuscript submission.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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