Eswatini Ring Study: Increasing PrEP Options for Women

NCT ID: NCT05889533

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

904 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-09

Study Completion Date

2025-01-27

Brief Summary

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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

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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.

Conditions

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HIV Prevention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* HIV negative, 18 or older, not known to be pregnant or breastfeeding, and female at birth.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

FHI 360

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anita Hettema, MPH

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Sindy Matse, MPH

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health

Locations

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Dvokolwako Health Centre

Dvokolwako, , Eswatini

Site Status

Manzini KP Community Centre

Manzini, , Eswatini

Site Status

Matsapha Mobile Clinic

Matsapha, , Eswatini

Site Status

Mbabane Key Population (KP) Community Centre

Mbabane, , Eswatini

Site Status

Mbabane Public Health Unit

Mbabane, , Eswatini

Site Status

Motshane Clinic

Mbabane, , Eswatini

Site Status

Siphofaneni Inkhundla (DREAMS Outreach)

Siphofaneni, , Eswatini

Site Status

New Haven Clinic

Velebantfu, , Eswatini

Site Status

Countries

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Eswatini

Other Identifiers

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FHI 360

Identifier Type: -

Identifier Source: org_study_id

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