HIV Self-testingNCT07194902
HIV Self-testing for Partners of HIV-uninfected Postpartum Women
A study testing HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). in people with HIV Self-testing and Male Partners of HIV-negative Postpartum Women, run by Massachusetts General Hospital at 1 site in South Africa.
Trial summary
The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Self-testing, Male Partners of HIV-negative Postpartum Women, PrEP Uptake
- What is being tested?
- HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Africa
- Study dates
- 19 Mar 2026to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Female Inclusion Criteria:
- woman
- Age ≥18
- ≥30 weeks pregnant per medical record due date
- non-reactive third trimester HIV test (verified from their antenatal care chart)
- reporting at least one unknown-serostatus partner
- fluent in English or isiZulu
- willing to give researchers permission to contact them for repeated assessments
- able to provide informed consent
Male Inclusion Criteria: partners meeting the inclusion criteria as described above, and who complete verification questions to confirm their identity and status as the partners of the enrolled female participants. Additional inclusion criteria for men include:
- man
- Age ≥18
- partner of enrolled women, confirmed via couples verification tool
- fluent in English or isiZulu
- willing to give researchers permission to contact them
- able to provide informed consent.
Exclusion Criteria: Individuals with significant psychiatric illness that could interfere with participation or the ability to provide informed consent will be excluded at the discretion of the study team.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Wits MatCH Research Unit
Durban, KwaZulu-Natal
Jenni Smith, PhD, +27 31 001 1915, jsmit@mru.ac.za
About this study
Official title: HIV Self-testing for Partners of HIV-uninfected Postpartum Women to Facilitate PrEP and Antiretroviral Therapy Uptake to Promote HIV Treatment and Prevention
The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving. The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.
- Conditions
- HIV Self-testing, Male Partners of HIV-negative Postpartum Women, PrEP Uptake, Feasibility, Acceptability, HIV Prevention
- Being tested
- HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").
- Keywords
- HIV Prevention, PrEP, HIV Self-Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").Behavioural
For female participants, the intervention includes a 30-45 minute counseling session that will cover (1) SOC PrEP information, (2) communications skills training for HIVST kit distribution, (3) Motivational interviewing strategies (e.g., PrEP/HIVST pros/cons), (4) problem-solving barriers to PrEP uptake or HIVST distribution, (5) linkage enablers (e.g., care sites, transportation, asking questions of providers). For their male partners, an informative video will cover geographically diverse HIV treatment resources, as well as on why linkage to HIV care is needed in the context of the relationship with his female partner and gender norms. The video will also demonstrate a brief motivational exercise whereby men are asked to consider the pros and cons of linking to HIV care versus not (with examples), as well as a step-by-step guide to generate a concrete plan for linkage to care based on "linkage enablers".
| Study group | Role | What they receive |
|---|---|---|
| H4P Intervention Arm | Active comparator | At one of their last scheduled antenatal care visits (i.e., between 30- 40 weeks' gestation), all female participants will be provided with up to three HIVST kits for male partner distribution, and will be provided with information and a demonstration per the standard of care (SOC) for HIVST kit distribution. In addition to what female participants in the control arm engage in, they will engage in 30-45 minutes HIVST and PrEP uptake counseling intervention at the baseline visit. Male partners, in addition to the SOC written information provided to the control arm, will also receive a QR code linked to a brief video created by the study team. The video will communicate, among other things, information on geographically diverse HIV treatment resources, and why linkage to HIV care is needed in the context of the relationship (e.g., increased risk for HIV during the postpartum period, risk of transmission to infant during breastfeeding, his role in protecting the family's health). Receives: Behavioral: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). |
| Control Arm | Placebo comparator | At one of their last scheduled antenatal care visits (i.e., between 30- 40 weeks' gestation), all female participants will be provided with up to three HIVST kits for male partner distribution, and will receive 15-20 minutes of counseling. Female participants will receive OraQuick Rapid HIV-1/2 Antibody Tests. OraQuick kits will include step-by-step instructions on use and interpretation of results. All female participants will be provided with information and a demonstration per the standard of care (SOC) for HIVST kit distribution and will engage in a brief exercise that involves evaluating the pros and cons of offering HIVST kits to their partners. All men will be provided with the HIVST kit by their female partners (including directions for use, consistent with SOC), along with a letter describing how to contact the study team. Receives: Behavioral: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
To evaluate feasibility, the investigators will examine and report on (1) the number of participants (female and male) screened, eligible, and enrolled (whether > 70% of those screened enroll/agree to participate); (2) the number of female participants who distribute a kit to their male partner; the number of female participants who learn their male partner's status; and the number of male partners who use the kit, complete HIVST verification, use the QR code, and complete confirmatory testing.
Measured: Baseline and 3-month follow-up
Acceptability
Acceptability will be evaluated using the Client Satisfaction Questionnaire (CSQ8). The investigators will also record data on reasons for declining enrollment, and will document failure to distribute or use the kit, complete verification, and complete confirmatory testing. All qualitative exit interview data will be explored for categories and themes around intervention acceptability. Qualitative data will be analyzed using content analysis, an iterative, multi-step process as described by Miles and Huberman and Strauss and Corbin.
Measured: Post-Intervention
Safety concerns as a result of HIVST distribution
Safety will be evaluated via self-report of any safety concerns anticipated or experienced as a result of HIVST distribution including social, emotional, or physical harms. Female participants will be screened for partner violence (Abuse Assessment Screen) at baseline. If female participants report being a victim of violence, study staff will contact the local site PI/Co-PI (Smit/Mosery) and an appropriate clinical intervention will be delivered. Participants with elevated scores will be provided with a referral for mental health services, using referral systems that are already in place in Dr. Psaros' R01 (R01MH112385) and will be asked to not distribute the kits but stay in the study, as they might benefit from the intervention session. This will also be explored in qualitative interviews (as described above).
Measured: Baseline and 3-month follow-up
Preliminary effectiveness of H4P intervention.
Women: Preliminary effectiveness: Proportion of women whose male partners test positive or do not test/share result who initiate and use PrEP at 3 months postpartum, via self-report, and point of care test for tenofovir, via urine dipstick test which reflects use in the past few days.
Men: Preliminary effectiveness: Proportion of men with a positive test who link to care, via self-report and paper test result or CD4/viral load result from confirmatory testing, and copy of treatment regimen (or photographs of these documents).
Measured: 3-month follow-up
Challenges, successes, barriers, facilitators, and preferences for optimizing H4P intervention.
Qualitative exit interviews: Conducted with subsets of women and men assigned to the H4P intervention arm (based on HIV self-test kit distribution, kit use, and linkage) to explore challenges (including gender-based violence), successes, barriers (e.g., motivation to test for HIV during the postpartum period for men), facilitators, preferences around HIV self-test kit distribution (including use of Quick Response codes), HIV self-testing verification, confirmatory testing and verification, and linkage to care (e.g., PrEP or Antiretroviral Therapy, including how women decided to initiate PrEP, and experiences with PrEP linkage and clinic support around PrEP use), and opportunities to optimize the H4P intervention.
Measured: 3-month follow-up
Secondary outcomes (11)
Estimate PrEP uptake among female participants
The investigators will estimate PrEP uptake among female participants in a separate logistic regression model, adjusting for covariates carefully given the feasibility/acceptability design and small N.
Measured: 3-month follow-up
HIV and Pregnancy characteristics
Women: Results of HIV tests (3-month follow-up only); gravity, parity, number of weeks gestation when enrolled in Antenatal Care, ever offered PrEP, ever used PrEP, ever completed couples based counseling and testing. Pregnancy intention: Pregnancy Risk Assessment Monitoring System survey: Up to 4 items assessing attitudes and feelings about the most recent pregnancy.
Men: Date of last HIV test, ever completed couples-based counseling and testing, history of prior positive test (and date), whether currently taking Antiretroviral Therapy, and number of children. Referent pregnancy intention: Pregnancy Risk Assessment Monitoring System survey.
Measured: Baseline and 3-month follow-up
Physical health
Multi-Country Study on Women's Health and Violence Core Questionnaire Version 9: 43-item General Health section to measure overall health status and physical symptoms.
Measured: Baseline and 3-month follow-up
Depression
Women: Edinburgh Postnatal Depression Scale: 10-item scale widely used and validated in South Africa among both pregnant and postpartum women.
Men: Center for Epidemiologic Studies Depression scale: 20-item measure of depressive symptoms. High internal consistency; widely used in South Africa.
Measured: Baseline and 3-month follow-up
Substance Use
Addiction Severity Index-Lite: Assesses lifetime and recent substance use, including severity. Up to 111 items; previously used in South Africa.
Measured: Baseline and 3-month follow-up
Health beliefs
Women: Perceived Risk of HIV Infection Scale: 8-item measure of how people perceive their personal risk of HIV. Validated with women in Sub-Saharan Africa. PrEP Optimism: 3 items to assess beliefs about PrEP efficacy in preventing HIV. Items used among HIV-uninfected pregnant women and heterosexual couples in South Africa. Men: Antiretroviral Therapy treatment beliefs: Beliefs about Medicines Questionnaire: Two five-item scales assessing beliefs about the necessity of and concerns about taking prescribed medication. Used in Sub-Saharan Africa.
Measured: Baseline
Relationship characteristics and communication
Partner Communication Scale: 5-item measure of sexual communication between partners around condom use, HIV/STI prevention, pregnancy, and sexual history. Internal consistency has been established. Dyadic Trust Scale: 8- item measures of trust in close relationships. Used and validated in South Africa and other resource-limited settings. Gender-Equitable Men Scale: 24-item measure of attitudes towards gender relations. Used and validated among women in South Africa and other resource-limited settings. Sexual Relationship Power Scale: 23-item measure of decision-making dominance and relationship control. Validated among women in South Africa. Duration of relationship will be assessed.
Measured: Baseline and 3-month follow-up
Partner Violence
Women: Abuse Assessment Screen: 5-item measure of presence of violence in the last year. Clinical assessment conducted if answer is "yes" to ≥1 questions. Widely used among those who are pregnant and validated among pregnant women in resource-limited settings
Measured: Baseline and 3-month follow-up
HIV-related stigma
Personal Stigma and Attributed Stigma Scales: parallel 17-item scales to measure personal stigmatizing views about HIV and stigma attributed to others. Both scales validated among HIV-uninfected women in South Africa.
PrEP Use Stigma Scale: 6-item scale measuring internalized stigma related to HIV and PrEP use, adapted for use among young women in Zimbabwe and South Africa (Cronbach's alpha: 0.89).
Measured: Baseline and 3-month follow-up
Structural barriers
Modes and costs of transportation to travel to clinic, travel time to clinic visits, and the average amount of time spent at the clinic.
Measured: Baseline and 3-month follow-up
Demographics
Age; ethnicity; country of origin; educational level; employment status; occupation; income; religion; housing stability; with whom participant lives.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start19 Mar 2026
- Primary completion28 Aug 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV Self-testingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Christina Psaros, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194902
- Sponsor's protocol ID
- 2025P002271
- Other IDs
- R34MH132446
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Psaros C, Beesham I, Mosery N, Aoun ZR, Bhardwaj A, Ndlovu L, Ntanzi N, Pratt MC, Chikovore J, Smit JA, Matthews LT. HIV self-testing for partners of postpartum women to facilitate HIV pre-exposure prophylaxis and antiretroviral therapy uptake: a protocol to adapt and pilot an intervention via a pilot randomised controlled trial in South Africa. BMJ Open. 2026 Jun 9;16(6):e121917. doi: 10.1136/bmjopen-2026-121917.
PubMed 42264526
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Self-testing for Partners of HIV-uninfected Postpartum Women to Facilitate PrEP and Antiretroviral Therapy Uptake to Promote HIV Treatment and Prevention
- ClinicalTrials.gov ID
- NCT07194902
- Acronym / sponsor ID
- 2025P002271
- Conditions
- HIV Self-testing, Male Partners of HIV-negative Postpartum Women, PrEP Uptake, Feasibility, Acceptability, HIV Prevention
- Keywords
- HIV Prevention, PrEP, HIV Self-Testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 28 Aug 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 26 Sep 2025 (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 purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving. The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H4P Intervention Arm | Active comparator | Behavioral: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").At one of their last scheduled antenatal care visits (i.e., between 30- 40 weeks' gestation), all female participants will be provided with up to three HIVST kits for male partner distribution, and will be provided with information and a demonstration per the standard of care (SOC) for HIVST kit distribution. In addition to what female participants in the control arm engage in, they will engage in 30-45 minutes HIVST and PrEP uptake counseling intervention at the baseline visit. Male partners, in addition to the SOC written information provided to the control arm, will also receive a QR code linked to a brief video created by the study team. The video will communicate, among other things, information on geographically diverse HIV treatment resources, and why linkage to HIV care is needed in the context of the relationship (e.g., increased risk for HIV during the postpartum period, risk of transmission to infant during breastfeeding, his role in protecting the family's health). |
| Control Arm | Placebo comparator | Behavioral: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").At one of their last scheduled antenatal care visits (i.e., between 30- 40 weeks' gestation), all female participants will be provided with up to three HIVST kits for male partner distribution, and will receive 15-20 minutes of counseling. Female participants will receive OraQuick Rapid HIV-1/2 Antibody Tests. OraQuick kits will include step-by-step instructions on use and interpretation of results. All female participants will be provided with information and a demonstration per the standard of care (SOC) for HIVST kit distribution and will engage in a brief exercise that involves evaluating the pros and cons of offering HIVST kits to their partners. All men will be provided with the HIVST kit by their female partners (including directions for use, consistent with SOC), along with a letter describing how to contact the study team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").For female participants, the intervention includes a 30-45 minute counseling session that will cover (1) SOC PrEP information, (2) communications skills training for HIVST kit distribution, (3) Motivational interviewing strategies (e.g., PrEP/HIVST pros/cons), (4) problem-solving barriers to PrEP uptake or HIVST distribution, (5) linkage enablers (e.g., care sites, transportation, asking questions of providers). For their male partners, an informative video will cover geographically diverse HIV treatment resources, as well as on why linkage to HIV care is needed in the context of the relationship with his female partner and gender norms. The video will also demonstrate a brief motivational exercise whereby men are asked to consider the pros and cons of linking to HIV care versus not (with examples), as well as a step-by-step guide to generate a concrete plan for linkage to care based on "linkage enablers". | Behavioural | Control Arm, H4P Intervention Arm |
Primary outcome
Feasibility of intervention
Time frame: Baseline and 3-month follow-up
To evaluate feasibility, the investigators will examine and report on (1) the number of participants (female and male) screened, eligible, and enrolled (whether > 70% of those screened enroll/agree to participate); (2) the number of female participants who distribute a kit to their male partner; the number of female participants who learn their male partner's status; and the number of male partners who use the kit, complete HIVST verification, use the QR code, and complete confirmatory testing.
Acceptability
Time frame: Post-Intervention
Acceptability will be evaluated using the Client Satisfaction Questionnaire (CSQ8). The investigators will also record data on reasons for declining enrollment, and will document failure to distribute or use the kit, complete verification, and complete confirmatory testing. All qualitative exit interview data will be explored for categories and themes around intervention acceptability. Qualitative data will be analyzed using content analysis, an iterative, multi-step process as described by Miles and Huberman and Strauss and Corbin.
Safety concerns as a result of HIVST distribution
Time frame: Baseline and 3-month follow-up
Safety will be evaluated via self-report of any safety concerns anticipated or experienced as a result of HIVST distribution including social, emotional, or physical harms. Female participants will be screened for partner violence (Abuse Assessment Screen) at baseline. If female participants report being a victim of violence, study staff will contact the local site PI/Co-PI (Smit/Mosery) and an appropriate clinical intervention will be delivered. Participants with elevated scores will be provided with a referral for mental health services, using referral systems that are already in place in Dr. Psaros' R01 (R01MH112385) and will be asked to not distribute the kits but stay in the study, as they might benefit from the intervention session. This will also be explored in qualitative interviews (as described above).
Preliminary effectiveness of H4P intervention.
Time frame: 3-month follow-up
Women: Preliminary effectiveness: Proportion of women whose male partners test positive or do not test/share result who initiate and use PrEP at 3 months postpartum, via self-report, and point of care test for tenofovir, via urine dipstick test which reflects use in the past few days. Men: Preliminary effectiveness: Proportion of men with a positive test who link to care, via self-report and paper test result or CD4/viral load result from confirmatory testing, and copy of treatment regimen (or photographs of these documents).
Challenges, successes, barriers, facilitators, and preferences for optimizing H4P intervention.
Time frame: 3-month follow-up
Qualitative exit interviews: Conducted with subsets of women and men assigned to the H4P intervention arm (based on HIV self-test kit distribution, kit use, and linkage) to explore challenges (including gender-based violence), successes, barriers (e.g., motivation to test for HIV during the postpartum period for men), facilitators, preferences around HIV self-test kit distribution (including use of Quick Response codes), HIV self-testing verification, confirmatory testing and verification, and linkage to care (e.g., PrEP or Antiretroviral Therapy, including how women decided to initiate PrEP, and experiences with PrEP linkage and clinic support around PrEP use), and opportunities to optimize the H4P intervention.
11 secondary outcomes
Estimate PrEP uptake among female participants
Time frame: 3-month follow-up
HIV and Pregnancy characteristics
Time frame: Baseline and 3-month follow-up
Physical health
Time frame: Baseline and 3-month follow-up
Depression
Time frame: Baseline and 3-month follow-up
Substance Use
Time frame: Baseline and 3-month follow-up
Health beliefs
Time frame: Baseline
Relationship characteristics and communication
Time frame: Baseline and 3-month follow-up
Partner Violence
Time frame: Baseline and 3-month follow-up
HIV-related stigma
Time frame: Baseline and 3-month follow-up
Structural barriers
Time frame: Baseline and 3-month follow-up
Demographics
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 42264526Psaros C, Beesham I, Mosery N, Aoun ZR, Bhardwaj A, Ndlovu L, Ntanzi N, Pratt MC, Chikovore J, Smit JA, Matthews LT. HIV self-testing for partners of postpartum women to facilitate HIV pre-exposure prophylaxis and antiretroviral therapy uptake: a protocol to adapt and pilot an intervention via a pilot randomised controlled trial in South Africa. BMJ Open. 2026 Jun 9;16(6):e121917. doi: 10.1136/bmjopen-2026-121917.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). in people with HIV Self-testing and Male Partners of HIV-negative Postpartum Women, run by Massachusetts General Hospital 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?
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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: Baseline and 3-month follow-up). 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?
On the ClinicalTrials.gov record for NCT07194902, which also lists 1 linked publication.
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 23 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.