PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk

NCT06030856 | Unknown

• 1 other identifier: PALESA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomized trial among 50 AGYW (aged ≥16≤18 years), who discontinued PrEP use within the past 6 months, assigned in a 1:1 ratio to receive: 1) STI self-test kits (Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)) with in-person instruction at enrolment and telephone/video-based instructions for home use coupled with self-administered behavioural risk assessment or 2) self-administered behavioural risk assessment only (standard of care). All participants will receive comprehensive sexual and reproductive health (SRH) services during their study visits including choice of family planning method initiation and support, and behavioural HIV/STI risk reduction counselling.

Conditions

HIV Prevention

Keywords

Pre-Exposure Prophylaxis; HIV; Sexually Transmitted Infection (STI)

Outcome Measures

Primary Outcomes (5)

• Number of participants enrolled and retained in the PALESA study

  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

  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

  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

  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

  In-Depth Interviews will be conducted to collect participant's experience while in the study and tools used during the study.

  1 year

Study Arms (2)

STI test kits for home use coupled with self-administered behavioural risk assessment

EXPERIMENTAL

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.

Device: STI test kits (NG, CT and TV) for home use; Behavioral: Self Administered Behavioural Risk Assessment

Self-administered behavioural risk assessment only (standard of care)

ACTIVE COMPARATOR

The adolescent will receive a self-administered behavioural risk assessment at the screening and enrolment visit

Behavioral: Self Administered Behavioural Risk Assessment

Interventions

STI test kits (NG, CT and TV) for home use DEVICE

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.

STI test kits for home use coupled with self-administered behavioural risk assessment

Self Administered Behavioural Risk Assessment BEHAVIORAL

Self Administered assessment to determine risk of HIV, STIs and pregnancy

STI test kits for home use coupled with self-administered behavioural risk assessment; Self-administered behavioural risk assessment only (standard of care)

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wits RHI Research Centre Clinical Research Site: lead
• University of Alabama at Birmingham: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

Wits RHI Research Centre

Hillbrow, Gauteng, 2038, South Africa

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thesla Palanee-Phillips

CONTACT

11 358 5471; TPalanee@wrhi.ac.za

Krishnaveni Reddy

CONTACT

11 358 5470; KReddy@wrhi.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director:Clinical Trials

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 11, 2023
• Study Start: July 5, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Access Criteria: A data request from the PI needs to be made before the data can be released

Locations

ZA (1)