Clinical trial NCT05889533: Eswatini Ring Study: Increasing PrEP Options for Women
Official title: Increasing PrEP Options for Women in Eswatini: A Prospective Mixed Methods Study on the Introduction of the PrEP Vaginal Ring
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV Prevention
Keywords: HIV prevention
PrEP
AGYW
PrEP Ring
Eswatini
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2023-06-05
Enrollment: 904
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those meeting eligibility criteria seeking PrEP services at study sites.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Characterize implementation of the service delivery package for informed PrEP choice for women
timeFrame: 18 months
Secondary outcomes:
measure: Describe patterns of PrEP use in the context of informed PrEP choice
timeFrame: 18 months
Other outcomes:
measure: Describe clinically relevant indicators among PrEP users, including rates of seroconversion and drug resistance among PEP users who acquire HIV following PrEP initiation.
timeFrame: 18 months
Locations:
city: Dvokolwako
country: Eswatini
facility: Dvokolwako Health Centre
city: Manzini
country: Eswatini
facility: Manzini KP Community Centre
city: Matsapha
country: Eswatini
facility: Matsapha Mobile Clinic
city: Mbabane
country: Eswatini
facility: Mbabane Key Population (KP) Community Centre
city: Mbabane
country: Eswatini
facility: Mbabane Public Health Unit
city: Mbabane
country: Eswatini
facility: Motshane Clinic
city: Siphofaneni
country: Eswatini
facility: Siphofaneni Inkhundla (DREAMS Outreach)
city: Velebantfu
country: Eswatini
facility: New Haven Clinic
Study officials:
affiliation: FHI 360
name: Anita Hettema, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health
name: Sindy Matse, MPH
role: PRINCIPAL_INVESTIGATOR
References: