PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk
NCT ID: NCT06030856
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-07-05
2024-08-31
Brief Summary
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Detailed Description
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This overall study comprises two components that include a formative research study enrolling \~60 participants for qualitative in-depth interviews (IDIs) (this has been completed) and a prospective cohort study (Pilot randomized controlled trial - RCT) enrolling 50 AGYW with both clinical, diagnostic laboratory and nested qualitative methodologies.
The RCT seeks to establish the feasibility of conducting a randomized controlled trial among AGYW in South Africa to determine the impact of decentralized or at-home STI testing \[(for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)\] on restarting PrEP relative to a self-administered behavioural risk assessment. Additionally qualitative interviews will be conducted to assess adolescent girls experiences of at-home STI testing, behavioural risk assessment, and re-starting PrEP while participating in the pilot trial through exit interviews.
Objective 1: To determine the feasibility and acceptability of conducting a RCT among South African AGYW to determine the impact of STI self-testing coupled with a self-administered behavioural risk assessment on restarting PrEP relative to a self-administered behavioural risk assessment only
Objective 2: To assess AGYW acceptability of and experiences with use at-home STI testing, self-administered behavioural risk assessment, and re-starting PrEP while participating in the pilot RCT
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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STI test kits for home use coupled with self-administered behavioural risk assessment
The adolescent will receive STI test kits (NG, CT and TV) for home use coupled with self-administered behavioural risk assessment at the screening and enrolment visit.
STI test kits (NG, CT and TV) for home use
The adolescent randomized to the at-home STI testing arm will be provided with in-person instruction at enrollment and flyers (in English and isiZulu) with printed step-by-step instructions for kit use. Information will include details on how to store the kits, criteria for adequate specimen collection and preparation, how to run the test, and how to interpret the test results. Video-based instructions with accompanying text subtitles and audio options may also be provided for home use.
Self Administered Behavioural Risk Assessment
Self Administered assessment to determine risk of HIV, STIs and pregnancy
Self-administered behavioural risk assessment only (standard of care)
The adolescent will receive a self-administered behavioural risk assessment at the screening and enrolment visit
Self Administered Behavioural Risk Assessment
Self Administered assessment to determine risk of HIV, STIs and pregnancy
Interventions
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STI test kits (NG, CT and TV) for home use
The adolescent randomized to the at-home STI testing arm will be provided with in-person instruction at enrollment and flyers (in English and isiZulu) with printed step-by-step instructions for kit use. Information will include details on how to store the kits, criteria for adequate specimen collection and preparation, how to run the test, and how to interpret the test results. Video-based instructions with accompanying text subtitles and audio options may also be provided for home use.
Self Administered Behavioural Risk Assessment
Self Administered assessment to determine risk of HIV, STIs and pregnancy
Eligibility Criteria
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Inclusion Criteria
* Be cis-gender adolescent females (16-20 years of age)
* Be literate
* Currently sexually active
* Be willing to participate in in-person and virtual study visits
* Not be pregnant or planning to be pregnant for the next 6 months
* Be HIV-negative but not ready to initiate PrEP at the screening and enrolment visit
* Have used PrEP with subsequent discontinuation within the last 6 months
* Have no contraindications to oral PrEP per self-report
* Have no indication of possible acute HIV infection, according to South African PrEP guidelines
* Have their own personal smart phone
* Willing to provide written informed consent/assent to participate in this study
For the subset invited to qualitative interviews, all participants must be:
• Willing to participate in an IDI at/before their month 6 visit (study exit visit)
Exclusion Criteria
* At Screening and Enrollment, parent/guardian (for those participants \<18 years) is unwilling to provide written informed consent
* At Screening and Enrollment, is already participating in another research study involving drugs, medical devices, or vaccines for STI prevention or treatment.
* Is not willing to comply with study procedures
* As determined by the PIs/designee, any current or historical physical health, mental health or social issue or condition that the site investigator or designee determines should exclude participation.
* Has any other condition that, in the opinion of the PIs/designee, would preclude informed consent, make study participation unsafe, or otherwise interfere with achieving the study objectives.
16 Years
20 Years
FEMALE
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
University of California, San Francisco
OTHER
Wits RHI Research Centre Clinical Research Site
OTHER
Responsible Party
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Thesla Palanee-Phillips
Director:Clinical Trials
Locations
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Wits RHI Research Centre
Hillbrow, Gauteng, South Africa
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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PALESA
Identifier Type: -
Identifier Source: org_study_id
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