Eswatini Ring Study: Increasing PrEP Options for Women | NCT05889533

Studies
Eswatini Ring Study: Increasing PrEP Options for Women

NCT05889533

Sponsor

FHI 360

Status

Terminated

Last Update Posted

Mar 18, 2025Actual

Enrollment

904Actual

Phase

Not provided

Conditions

HIV Prevention

Interventions

Not provided

Countries

Eswatini

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped due to the stop work order issued by USAID on January 27, 2025

Expanded Access Info

Start Date

May 9, 2023Actual

Primary Completion Date

Jan 27, 2025Actual

Completion Date

Jan 27, 2025Actual

First Submitted Date

May 26, 2023

First Submission Date that Met QC Criteria

May 26, 2023

First Posted Date

Jun 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2025

Last Update Posted Date

Mar 18, 2025Actual

Name	Class
United States Agency for International Development (USAID)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The two main study components include the following:

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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

904Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

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.	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Those meeting eligibility criteria seeking PrEP services at study sites.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anita Hettema, MPH	FHI 360	Principal Investigator
Sindy Matse, MPH	Ministry of Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dvokolwako Health Centre		Dvokolwako			Eswatini
Manzini KP Community Centre

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

After study completion and manuscript submission.

Access Criteria

Not provided

URL

Not provided