Skip to content

Eswatini Ring Study: Increasing PrEP Options for Women

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05889533
Enrollment
904
Registered
2023-06-05
Start date
2023-05-09
Completion date
2025-01-27
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention

Keywords

HIV prevention, PrEP, AGYW, PrEP Ring, Eswatini

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 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.

Interventions

None listed

Sponsors

United States Agency for International Development (USAID)
CollaboratorFED
FHI 360
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Characterize implementation of the service delivery package for informed PrEP choice for women18 monthsHealth system feasibility and delivery acceptance among users/providers

Secondary

MeasureTime frameDescription
Describe patterns of PrEP use in the context of informed PrEP choice18 monthsOverall and method-specific PrEP uptake; continuation/switching/discontinuation of PrEP products; product acceptability among users.

Other

MeasureTime frameDescription
Describe clinically relevant indicators among PrEP users, including rates of seroconversion and drug resistance among PEP users who acquire HIV following PrEP initiation.18 monthsProportion and rates of HIV infection among participants; proportion and rates of HIV drug resistance (DR) mutations among PrEP users who acquire HIV.

Countries

Eswatini

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026