HIV PreventionNCT05889533
Eswatini Ring Study: Increasing PrEP Options for Women
An observational study of HIV Prevention, run by FHI 360 at 8 sites in Eswatini.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- How many people
- 904 participants
- Where
- 8 sitesEswatini
- Study dates
- 9 May 2023to 27 Jan 2025
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Those meeting eligibility criteria seeking PrEP services at study sites.
Who may be able to join
- HIV negative, 18 or older, not known to be pregnant or breastfeeding, and female at birth.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Eswatini8 sites
Dvokolwako Health Centre
Dvokolwako
Manzini KP Community Centre
Manzini
Matsapha Mobile Clinic
Matsapha
Mbabane Key Population (KP) Community Centre
Mbabane
Mbabane Public Health Unit
Mbabane
Motshane Clinic
Mbabane
Siphofaneni Inkhundla (DREAMS Outreach)
Siphofaneni
New Haven Clinic
Velebantfu
About this study
Official title: Increasing PrEP Options for Women in Eswatini: A Prospective Mixed Methods Study on the Introduction of the PrEP Vaginal Ring
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.
Read the 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:
- 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.
- Conditions
- HIV Prevention
- Keywords
- HIV prevention, PrEP, AGYW, PrEP Ring, Eswatini
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize implementation of the service delivery package for informed PrEP choice for women
Health system feasibility and delivery acceptance among users/providers
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start9 May 2023
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Why it stopped: Study was stopped due to the stop work order issued by USAID on January 27, 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 904 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Anita Hettema, MPH, Principal investigator, FHI 360Sindy Matse, MPH, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889533
- Sponsor's protocol ID
- FHI 360
- Status last verified
- Mar 2025
- First submitted
- 26 May 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing PrEP Options for Women in Eswatini: A Prospective Mixed Methods Study on the Introduction of the PrEP Vaginal Ring
- ClinicalTrials.gov ID
- NCT05889533
- Acronym / sponsor ID
- FHI 360
- Conditions
- HIV Prevention
- Keywords
- HIV prevention, PrEP, AGYW, PrEP Ring, Eswatini
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was stopped due to the stop work order issued by USAID on January 27, 2025
- Enrolment
- 904 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 9 May 2023 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those meeting eligibility criteria seeking PrEP services at study sites.
Key inclusion criteria (1 listed)
- HIV negative, 18 or older, not known to be pregnant or breastfeeding, and female at birth.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize implementation of the service delivery package for informed PrEP choice for women
Time frame: 18 months
Health system feasibility and delivery acceptance among users/providers
1 secondary outcome
Describe patterns of PrEP use in the context of informed PrEP choice
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Study was stopped due to the stop work order issued by USAID on January 27, 2025). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for HIV Prevention
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Active, not recruiting
Implementing PrEP for Women Who Inject Drugs
HIV, Intravenous Substance Abuse
Not yet recruiting
mHealth Service Linkage for Young Adults Impacted by the Criminal Legal System
HIV Prevention, Substance Use
RecruitingPhase 4
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
HIV Prevention, HIV Pre-exposure Prophylaxis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Hettema, MPH principal investigator
FHI 360
Sindy Matse, MPH principal investigator
Ministry of Health
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention, run by FHI 360 at 8 sites in Eswatini.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was stopped due to the stop work order issued by USAID on January 27, 2025). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize implementation of the service delivery package for informed PrEP choice for women (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.