NCT05889533

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
904

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.7 years

First QC Date

May 26, 2023

Last Update Submit

March 13, 2025

Conditions

HIV Prevention

Keywords

HIV preventionPrEPAGYWPrEP RingEswatini

Outcome Measures

Primary Outcomes (1)

  • Characterize implementation of the service delivery package for informed PrEP choice for women

    Health system feasibility and delivery acceptance among users/providers

    18 months

Secondary Outcomes (1)

  • Describe patterns of PrEP use in the context of informed PrEP choice

    18 months

Other Outcomes (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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those meeting eligibility criteria seeking PrEP services at study sites.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Dvokolwako Health Centre

Dvokolwako, Eswatini

Location

Manzini KP Community Centre

Manzini, Eswatini

Location

Matsapha Mobile Clinic

Matsapha, Eswatini

Location

Mbabane Key Population (KP) Community Centre

Mbabane, Eswatini

Location

Mbabane Public Health Unit

Mbabane, Eswatini

Location

Motshane Clinic

Mbabane, Eswatini

Location

Siphofaneni Inkhundla (DREAMS Outreach)

Siphofaneni, Eswatini

Location

New Haven Clinic

Velebantfu, Eswatini

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Study Officials

  • Anita Hettema, MPH

    FHI 360

    PRINCIPAL INVESTIGATOR

  • Sindy Matse, MPH

    Ministry of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 5, 2023

Study Start

May 9, 2023

Primary Completion

January 27, 2025

Study Completion

January 27, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After study completion and manuscript submission.

Locations

ES(8)