Eswatini Ring Study: Increasing PrEP Options for Women

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889533
• Other study ID #: FHI 360
• Status: Recruiting
• Start date: May 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: FHI 360
• Contact: Anita Hettema, MPH
• Phone: +26876751498
• Email: Ahettema[@]fhi360.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• HIV Prevention

Locations

Country	Name	City	State
Swaziland	Dvokolwako Health Centre	Dvokolwako
Swaziland	Manzini KP Community Centre	Manzini
Swaziland	Matsapha Mobile Clinic	Matsapha
Swaziland	Mbabane Key Population (KP) Community Centre	Mbabane
Swaziland	Mbabane Public Health Unit	Mbabane
Swaziland	Motshane Clinic	Mbabane
Swaziland	Siphofaneni Inkhundla (DREAMS Outreach)	Siphofaneni
Swaziland	New Haven Clinic	Velebantfu

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	United States Agency for International Development (USAID)

Country where clinical trial is conducted

Swaziland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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