HIV PreventionPALESANCT06030856
PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk
A study testing STI test kits (NG, CT and TV) for home use and Self Administered Behavioural Risk Assessment in people with HIV Prevention, run by Wits RHI Research Centre Clinical Research Site at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- STI test kits (NG, CT and TV) for home use and Self Administered Behavioural Risk Assessment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Africa
- Study dates
- 5 Jul 2023to Aug 2024
- Phase
- Interventional
- 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 16 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
Wits RHI Research Centre
Hillbrow, Gauteng, 2038
Thesla Palanee-Phillips, 11 358 5471 ext. +27, TPalanee@wrhi.ac.za
Krishnaveni Reddy, 11 358 5470 ext. +27, KReddy@wrhi.ac.za
About this study
Official title: 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
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.
Read the 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
- Conditions
- HIV Prevention
- Being tested
- STI test kits (NG, CT and TV) for home use, Self Administered Behavioural Risk Assessment
- Keywords
- Pre-Exposure Prophylaxis, HIV, Sexually Transmitted Infection (STI)
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI test kits (NG, CT and TV) for home useDevice
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 AssessmentBehavioural
Self Administered assessment to determine risk of HIV, STIs and pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Self Administered Behavioural Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start5 Jul 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wits RHI Research Centre Clinical Research Site
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thesla Palanee-Phillips, Wits RHI Research Centre Clinical Research Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030856
- Sponsor's protocol ID
- PALESA
- Acronym
- PALESA
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all outcome measures will be made available after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06030856
- Acronym / sponsor ID
- PALESA / PALESA
- Conditions
- HIV Prevention
- Keywords
- Pre-Exposure Prophylaxis, HIV, Sexually Transmitted Infection (STI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wits RHI Research Centre Clinical Research SiteUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of California, San Francisco
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 11 Sep 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STI test kits for home use coupled with self-administered behavioural risk assessment | Experimental | Device: STI test kits (NG, CT and TV) for home use, Behavioral: Self Administered Behavioural Risk AssessmentThe 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. |
| Self-administered behavioural risk assessment only (standard of care) | Active comparator | Behavioral: Self Administered Behavioural Risk AssessmentThe adolescent will receive a self-administered behavioural risk assessment at the screening and enrolment visit |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- For the full cohort, all participants must:
- Willing to participate in an IDI at/before their month 6 visit (study exit visit)
Key exclusion criteria (6 listed)
- Potential AGYW participants who meet any of the following criteria will be excluded from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STI test kits (NG, CT and TV) for home useThe 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. | Device | STI test kits for home use coupled with self-administered behavioural risk assessment |
| Self Administered Behavioural Risk AssessmentSelf Administered assessment to determine risk of HIV, STIs and pregnancy | Behavioural | STI test kits for home use coupled with self-administered behavioural risk assessment, Self-administered behavioural risk assessment only (standard of care) |
Primary outcome
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
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.
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all outcome measures will be made available after study completion.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STI test kits (NG, CT and TV) for home use and Self Administered Behavioural Risk Assessment in people with HIV Prevention, run by Wits RHI Research Centre Clinical Research Site at 1 site in South Africa.
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 14 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thesla Palanee-Phillips (11 358 5471 ext. +27, TPalanee@wrhi.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants enrolled and retained in the PALESA study (time frame: 1 year). The study lists 5 primary outcomes in all. 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 11 Sep 2023.