- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06030856
PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk (PALESA)
A Pilot Randomized Controlled Trial to Assess a Model of Decentralised STI-Self Testing and Risk Self-Assessment Among Adolescent Girls and Young Women in South Africa to Trigger PrEP Re-start
Study Overview
Status
Conditions
Detailed Description
The PALESA study aims to determine the feasibility of conducting a randomized controlled trial (RCT) to determine the impact of decentralized sexually transmitted infection (STI) point of care (POC) self-testing and risk self-assessment interventions to trigger pre-exposure prophylaxis (PrEP) re-start among adolescent girls and young women (AGYW) in South Africa at potential ongoing risk of re- acquiring STIs and HIV.
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thesla Palanee-Phillips
- Phone Number: +27 11 358 5471
- Email: TPalanee@wrhi.ac.za
Study Contact Backup
- Name: Krishnaveni Reddy
- Phone Number: +27 11 358 5470
- Email: KReddy@wrhi.ac.za
Study Locations
-
-
Gauteng
-
Hillbrow, Gauteng, South Africa, 2038
- Recruiting
- Wits RHI Research Centre
-
Contact:
- Thesla Palanee-Phillips
- Phone Number: +27 11 358 5471
- Email: TPalanee@wrhi.ac.za
-
Contact:
- Krishnaveni Reddy
- Phone Number: +27 11 358 5470
- Email: KReddy@wrhi.ac.za
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
For the full cohort, all participants must:
- 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:
Potential AGYW participants who meet any of the following criteria will be excluded from the study:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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 assessment to determine risk of HIV, STIs and pregnancy
|
Active Comparator: 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 assessment to determine risk of HIV, STIs and pregnancy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants enrolled and retained in the PALESA study
Time Frame: 1 year
|
A recruitment target of 50 adolescent girls and young women and over 90% retention of those participants is achieved
|
1 year
|
Assessing Risk of Acquiring HIV and STIs
Time Frame: 1 year
|
A self administered behavioural risk assessment questionnaire with 16 - 20 questions (which include questions on STI test results), which will tally up a score, will be used to measure how much counselling and guidance will the participants need to restart PrEP. A score of 0 - 7 means medium recommendation to restart PrEP. A score 8-15 means a strong recommendation to restart PrEP. Test results of STIs from the self-testing STI kit are shared on the self-administered behavioural risk assessment questionnaire. |
1 year
|
Number of participants that restarted PrEP
Time Frame: 1 year
|
There will be a dispensation form for every participant, this form will indicate if PrEP was restarted by the participant, and it will calculate include pill counts when PrEP bottles are returned to the research site
|
1 year
|
PrEP continuation 1 month after re-start
Time Frame: 1 year
|
Dried Blood Spot (DBS) collected to measure tenofovir diphosphate (TFV-DP) level as an objective assessment of adherence to PrEP.
|
1 year
|
Experiences of at-home STI testing, self-administered behavioural risk assessment, and re-starting PrEP
Time Frame: 1 year
|
In-Depth Interviews will be conducted to collect participant's experience while in the study and tools used during the study.
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PALESA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Prevention
-
Prof Mags BeksinskaCompletedHIV Prevention | Pregnancy PreventionSouth Africa
-
Yale UniversityCompletedHIV Prevention | STI PreventionUnited States
-
Centers for Disease Control and PreventionUniversity of Minnesota; The Fenway Institute; AIDS Action Committee of Massachusetts and other collaboratorsCompletedHIV Prevention | STD PreventionUnited States
-
International Partnership for Microbicides, Inc.CompletedHIV PreventionSouth Africa, Uganda
-
Microbicide Trials NetworkNational Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy... and other collaboratorsCompleted
-
Fenway Community HealthCompleted
-
University of California, Los AngelesUniversity of California, San Diego; California HIV/AIDS Research Program; Los... and other collaboratorsCompletedHIV PreventionUnited States
-
Microbicide Trials NetworkNational Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy... and other collaboratorsCompletedHIV PreventionUganda, South Africa, Zimbabwe
-
Massachusetts General HospitalMbarara University of Science and TechnologyCompleted
-
Orion Biotechnology Polska Sp. z o.o.Scope International AGCompleted
Clinical Trials on STI test kits (NG, CT and TV) for home use
-
Duke UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedSexually Transmitted Infections | Chlamydia Trachomatis Infection | Neisseria Gonorrhoeae InfectionUnited States
-
London School of Hygiene and Tropical MedicineUniversity College, London; World Health Organization; UNITAID; Liverpool School... and other collaboratorsCompleted
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingHIV Infections | Sexually Transmitted Diseases, Bacterial | Pre-Exposure ProphylaxisUganda
-
Norwegian University of Science and TechnologyUniversity of Oslo; Kathmandu University School of Medical Sciences; Universiteit...Not yet recruitingSexually Transmitted Diseases | Vaginal Discharge
-
World Health OrganizationLondon School of Hygiene and Tropical Medicine; University of Ghana; Biomedical... and other collaboratorsRecruitingHealth-Related Behavior | Adolescent Behavior | Adolescent Development | Health Care Seeking BehaviorGhana, Tanzania, Zimbabwe