HIV InfectionsADDONCT05357144
AmbassADDOrs for Health Study
A study testing Loyalty card program at drug shops & supply of HIVST and SRH products and Comparison drug shops in people with HIV Infections, run by University of California, San Francisco at 2 sites in Tanzania.
Trial summary
The goal of the study is to evaluate Malkia Klabu ("Queen Club") in Tanzania, a loyalty program intervention that creates adolescent girls and young women (AGYW)-friendly drug shops where AGYW can access HIV prevention services and contraception. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Loyalty card program at drug shops & supply of HIVST and SRH products and Comparison drug shops
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 2 sitesTanzania
- Study dates
- 26 Jul 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Wards with no greater than 3 public health facilities;
- Wards with no less than 4 drug shops;
- Wards with health facilities that were greater than 20 KM from a primary or secondary road; and
- Drug shop owners and staff in Shinyanga and Mwanza Regions of Tanzania who are aged 18 or older;
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: AmbassADDOrs for Health: Supporting Young Women's Health Through Girl-friendly Drug Vendors
The goal of the study is to evaluate Malkia Klabu ("Queen Club") in Tanzania, a loyalty program intervention that creates adolescent girls and young women (AGYW)-friendly drug shops where AGYW can access HIV prevention services and contraception.
Read the detailed description
The investigators will conduct a cluster-randomized controlled trial of the Malkia Klabu intervention in 40 health facility catchment areas (n=60-70 intervention drug shops; ~3-4 drug shops per area) in the Shinyanga and Mwanza regions of Tanzania, plus a mixed-methods, implementation science study to pinpoint supply-side factors influencing effectiveness (e.g., implementation models, intervention fidelity, shop characteristics).
Malkia Klabu is a loyalty card program derived from a youth participatory process with human centered design. Young women earn punches on the Malkia Klabu loyalty card when they make drug shop purchases that upon accrual can be used towards prizes of increasing value. When joining, young women receive a free HIV self test kit (HIVST) as an opt out sign-up gift, are invited to interact with a physical display of sexual and reproductive health products, including HIVST, and may elect to view videos on a tablet computer about the program, HIVST, and contraception. The back of the card displays discreet symbols representing sensitive products available at the shop (e.g., HIVST, oral contraception). Club members can ask for or point to the product that they want on the card and receive it for free in a discreet bag. Referrals are provided to youth-friendly services at a nearby catchment area health facility for HIV testing, treatment and care, and/or contraception.
- Conditions
- HIV Infections
- Being tested
- Loyalty card program at drug shops & supply of HIVST and SRH products, Comparison drug shops
- Keywords
- HIV self-testing, Human-centred design, Adolescent health, Contraception, Drug shops
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loyalty card program at drug shops & supply of HIVST and SRH productsBehavioural
Consenting drug shops will receive:
- training on Malkia Klabu implementation;
- HIVST training (same as comparison drug shops);
- procedures for referring to youth-friendly HIV/SRH services;
- a monthly supply of HIVST reserved for free distribution to AGYW, with "free" price stickers and pre-packaged with referral information; and
- reimbursement for SRH products given to AGYW (e.g., birth control pills).
Comparison drug shopsBehavioural
Consenting drug shops in the comparison arm catchment areas will have access to the Maisha Meds inventory management application system for offline digital recording of HIVST, HIVST kits earmarked for free to AGYW, guidance on HIV care referral plan to facilitate linkage to nearby health facilities for AGYW. These control drug shops will not participate in Malkia Klabu (Queen Club) program implementation.
| Study group | Role | What they receive |
|---|---|---|
| Drug shops, also known as Accredited Drug Dispensing Outlets (ADDOs), owners or staff | Experimental | All drug shopkeepers in intervention areas (within Shinyanga or Mwanza) will be invited to participate in Malkia Klabu, a loyalty card program. Consenting drug shops in intervention areas should be willing and able to keep records of referrals and sexual and reproductive health (SRH) product distribution given to AGYW through the use of Maisha Meds during the one month run-in period. Receives: Behavioral: Loyalty card program at drug shops & supply of HIVST and SRH products |
| Shopkeepers in control arm for comparison area | Placebo comparator | Drug shopkeepers, staff and/or owners as part of the control arm will receive standard HIV training, guidance on referring AGYW to proximal HIV care, and HIVST for free distribution to AGYW. Receives: Behavioral: Comparison drug shops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative HIV Diagnoses Among 15-24 Year Old Females
Cumulative HIV-positive tests among 15-24 year old females at 12-15 months from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level.
Measured: 12-15 months
Antenatal Care Registrations by 15-24 Year Old Females
Cumulative antenatal care registrations among 15-24 year old females at 12-15 months from routinely collected health facility data, disaggregated by age, aggregated to the catchment area level.
Measured: 12-15 months
Secondary outcomes (7)
ART Initiation Among Newly Diagnosed AGYW
Data on antiretroviral therapy (ART) initiation abstracted from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level.
Measured: 12-15 months
Distribution of HIV Self-test Kits to Adolescent Girls and Young Women
Distribution of HIV self-test kits (HIVST) to adolescent girls and young women (AGYW) will be documented in Maisha Meds, a point of sales inventory system to be used by participating drug shops in both arms. This will be a continuous variable with a lower limit of zero and an undefined upper limit and is the simple count of all HIVSTs distributed to AGYW who visit the shops.
Measured: 12-15 months
Distribution Contraception to Adolescent Girls and Young Women
Distribution of contraception to adolescent girls and young women (AGYW) will be documented in Maisha Meds, a point of sales inventory system to be used by participating drug shops in both arms. This will be a continuous variable with a lower limit of zero and an undefined upper limit and is the simple count of the combined total number of oral contraceptive pills, emergency contraception, and condoms sold to AGYW who visit the shops.
Measured: 12-15 months
Program Exposure
Self-reported data from adolescent girls and young women (AGYW) on exposure to Malkia Klabu (if any) will be collected during an endline survey. This will be a proportion defined as the number of AGYW who report ever receiving a Malkia Klabu card (i.e. enrolling) as the numerator over the total number of AGYW interviewed. The values will range from 0-100%.
Measured: 12-15 months
Recent HIV Testing
Self-reported data from adolescent girls and young women (AGYW) on recent HIV testing (if any) will be collected during an endline survey. This will be a proportion defined as the number of AGYW who report testing for HIV in the last 6 months as the numerator over the total number of AGYW interviewed. The values will range from 0-100%.
Measured: 12-15 months
Recent Pregnancy Testing
Self-reported data from adolescent girls and young women (AGYW) on recent pregnancy testing (if any) will be collected during an endline survey. This will be a proportion defined as the number of AGYW who report taking a pregnancy test in the last 6 months as the numerator over the total number of AGYW interviewed. The values will range from 0-100%.
Measured: 12-15 months
Unmet Need for Contraception
Self-reported data from adolescent girls and young women (AGYW) on contraceptive preferences, desires, and use (if any) will be collected during an endline survey. Unmet need is defined as the number of women who do not want to get pregnant but are not using a method of birth control and are sexually active. We will use the collected data to create a variable where the numerator is the number of women not using a method of birth control and do not desire to get pregnant over the total number of sexually active women.
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start26 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Unanticipated changes to Tanzania's government oversight structure led to the premature termination of the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Model description
- Randomized controlled trial; Catchment areas will be randomly assigned 1:1 to intervention or comparison arms (n=60-70 intervention drug shops; \~3-4 drug shops per area) using a constrained approach to ensure balance in key covariates.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Berkeley, Health for a Prosperous Nation, RTI International, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jenny X Liu, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357144
- Sponsor's protocol ID
- R01MH124516
- Other IDs
- R01MH124516
- Acronym
- ADDO
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2022
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will make the data and associated documentation available to users upon request and only under a data-sharing agreement with the study team that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
Publications
Hunter LA, McCoy SI, Rao A, Mnyippembe A, Hassan K, Njau P, Mfaume R, Liu JX. Designing drug shops for young women in Tanzania: applying human-centred design to facilitate access to HIV self-testing and contraception. Health Policy Plan. 2021 Nov 11;36(10):1562-1573. doi: 10.1093/heapol/czab084.
PubMed 34313728Liu J, Prach LM, Treleaven E, Hansen M, Anyanti J, Jagha T, Seaman V, Ajumobi O, Isiguzo C. The role of drug vendors in improving basic health-care services in Nigeria. Bull World Health Organ. 2016 Apr 1;94(4):267-75. doi: 10.2471/BLT.15.154666. Epub 2016 Feb 3.
PubMed 27034520Peters DH, Mirchandani GG, Hansen PM. Strategies for engaging the private sector in sexual and reproductive health: how effective are they? Health Policy Plan. 2004 Oct;19 Suppl 1:i5-i21. doi: 10.1093/heapol/czh041.
PubMed 15452011Corroon M, Kebede E, Spektor G, Speizer I. Key Role of Drug Shops and Pharmacies for Family Planning in Urban Nigeria and Kenya. Glob Health Sci Pract. 2016 Dec 28;4(4):594-609. doi: 10.9745/GHSP-D-16-00197. Print 2016 Dec 23.
PubMed 28031299Rutta E, Liana J, Embrey M, Johnson K, Kimatta S, Valimba R, Lieber R, Shekalaghe E, Sillo H. Accrediting retail drug shops to strengthen Tanzania's public health system: an ADDO case study. J Pharm Policy Pract. 2015 Sep 25;8:23. doi: 10.1186/s40545-015-0044-4. eCollection 2015.
PubMed 26413304Sieverding M, Schatzkin E, Shen J, Liu J. Bias in Contraceptive Provision to Young Women Among Private Health Care Providers in South West Nigeria. Int Perspect Sex Reprod Health. 2018 Mar 1;44(1):19-29. doi: 10.1363/44e5418.
PubMed 30028307Mnyippembe A, Sheira LA, McCoy SI, Njau PF, Packel LJ, Hassan K, Solorzano-Barrera C, Maokola W, Kang Dufour MS, Sabasaba A, Liu J. Supporting young women's health through girl-friendly drug vendors in Lake Zone, Tanzania: protocol for the AmbassADDOrs for Health cluster-randomised controlled trial. BMJ Open. 2024 Jun 8;14(6):e078755. doi: 10.1136/bmjopen-2023-078755.
PubMed 38851225
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AmbassADDOrs for Health: Supporting Young Women's Health Through Girl-friendly Drug Vendors
- ClinicalTrials.gov ID
- NCT05357144
- Acronym / sponsor ID
- ADDO / R01MH124516
- Conditions
- HIV Infections
- Keywords
- HIV self-testing, Human-centred design, Adolescent health, Contraception, Drug shops
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unanticipated changes to Tanzania's government oversight structure led to the premature termination of the trial.
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Berkeley, Health for a Prosperous Nation, RTI International, National Institute of Mental Health (NIMH)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Posted 20 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to evaluate Malkia Klabu ("Queen Club") in Tanzania, a loyalty program intervention that creates adolescent girls and young women (AGYW)-friendly drug shops where AGYW can access HIV prevention services and contraception.
Detailed description
The investigators will conduct a cluster-randomized controlled trial of the Malkia Klabu intervention in 40 health facility catchment areas (n=60-70 intervention drug shops; ~3-4 drug shops per area) in the Shinyanga and Mwanza regions of Tanzania, plus a mixed-methods, implementation science study to pinpoint supply-side factors influencing effectiveness (e.g., implementation models, intervention fidelity, shop characteristics).
Malkia Klabu is a loyalty card program derived from a youth participatory process with human centered design. Young women earn punches on the Malkia Klabu loyalty card when they make drug shop purchases that upon accrual can be used towards prizes of increasing value. When joining, young women receive a free HIV self test kit (HIVST) as an opt out sign-up gift, are invited to interact with a physical display of sexual and reproductive health products, including HIVST, and may elect to view videos on a tablet computer about the program, HIVST, and contraception. The back of the card displays discreet symbols representing sensitive products available at the shop (e.g., HIVST, oral contraception). Club members can ask for or point to the product that they want on the card and receive it for free in a discreet bag. Referrals are provided to youth-friendly services at a nearby catchment area health facility for HIV testing, treatment and care, and/or contraception.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial; Catchment areas will be randomly assigned 1:1 to intervention or comparison arms (n=60-70 intervention drug shops; ~3-4 drug shops per area) using a constrained approach to ensure balance in key covariates.
| Arm | Type | Receives |
|---|---|---|
| Drug shops, also known as Accredited Drug Dispensing Outlets (ADDOs), owners or staff | Experimental | Behavioral: Loyalty card program at drug shops & supply of HIVST and SRH productsAll drug shopkeepers in intervention areas (within Shinyanga or Mwanza) will be invited to participate in Malkia Klabu, a loyalty card program. Consenting drug shops in intervention areas should be willing and able to keep records of referrals and sexual and reproductive health (SRH) product distribution given to AGYW through the use of Maisha Meds during the one month run-in period. |
| Shopkeepers in control arm for comparison area | Placebo comparator | Behavioral: Comparison drug shopsDrug shopkeepers, staff and/or owners as part of the control arm will receive standard HIV training, guidance on referring AGYW to proximal HIV care, and HIVST for free distribution to AGYW. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Wards with no greater than 3 public health facilities;
- Wards with no less than 4 drug shops;
- Wards with health facilities that were greater than 20 KM from a primary or secondary road; and
- Drug shop owners and staff in Shinyanga and Mwanza Regions of Tanzania who are aged 18 or older;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Loyalty card program at drug shops & supply of HIVST and SRH productsConsenting drug shops will receive: * training on Malkia Klabu implementation; * HIVST training (same as comparison drug shops); * procedures for referring to youth-friendly HIV/SRH services; * a monthly supply of HIVST reserved for free distribution to AGYW, with "free" price stickers and pre-packaged with referral information; and * reimbursement for SRH products given to AGYW (e.g., birth control pills). | Behavioural | Drug shops, also known as Accredited Drug Dispensing Outlets (ADDOs), owners or staff |
| Comparison drug shopsConsenting drug shops in the comparison arm catchment areas will have access to the Maisha Meds inventory management application system for offline digital recording of HIVST, HIVST kits earmarked for free to AGYW, guidance on HIV care referral plan to facilitate linkage to nearby health facilities for AGYW. These control drug shops will not participate in Malkia Klabu (Queen Club) program implementation. | Behavioural | Shopkeepers in control arm for comparison area |
Primary outcome
Cumulative HIV Diagnoses Among 15-24 Year Old Females
Time frame: 12-15 months
Cumulative HIV-positive tests among 15-24 year old females at 12-15 months from routinely collected health facility data, disaggregated by sex and age, aggregated to the catchment area level.
Antenatal Care Registrations by 15-24 Year Old Females
Time frame: 12-15 months
Cumulative antenatal care registrations among 15-24 year old females at 12-15 months from routinely collected health facility data, disaggregated by age, aggregated to the catchment area level.
7 secondary outcomes
ART Initiation Among Newly Diagnosed AGYW
Time frame: 12-15 months
Distribution of HIV Self-test Kits to Adolescent Girls and Young Women
Time frame: 12-15 months
Distribution Contraception to Adolescent Girls and Young Women
Time frame: 12-15 months
Program Exposure
Time frame: 12-15 months
Recent HIV Testing
Time frame: 12-15 months
Recent Pregnancy Testing
Time frame: 12-15 months
Unmet Need for Contraception
Time frame: 12-15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34313728Hunter LA, McCoy SI, Rao A, Mnyippembe A, Hassan K, Njau P, Mfaume R, Liu JX. Designing drug shops for young women in Tanzania: applying human-centred design to facilitate access to HIV self-testing and contraception. Health Policy Plan. 2021 Nov 11;36(10):1562-1573. doi: 10.1093/heapol/czab084.
- Background: PubMed 27034520Liu J, Prach LM, Treleaven E, Hansen M, Anyanti J, Jagha T, Seaman V, Ajumobi O, Isiguzo C. The role of drug vendors in improving basic health-care services in Nigeria. Bull World Health Organ. 2016 Apr 1;94(4):267-75. doi: 10.2471/BLT.15.154666. Epub 2016 Feb 3.
- Background: PubMed 15452011Peters DH, Mirchandani GG, Hansen PM. Strategies for engaging the private sector in sexual and reproductive health: how effective are they? Health Policy Plan. 2004 Oct;19 Suppl 1:i5-i21. doi: 10.1093/heapol/czh041.
- Background: PubMed 28031299Corroon M, Kebede E, Spektor G, Speizer I. Key Role of Drug Shops and Pharmacies for Family Planning in Urban Nigeria and Kenya. Glob Health Sci Pract. 2016 Dec 28;4(4):594-609. doi: 10.9745/GHSP-D-16-00197. Print 2016 Dec 23.
- Background: PubMed 26413304Rutta E, Liana J, Embrey M, Johnson K, Kimatta S, Valimba R, Lieber R, Shekalaghe E, Sillo H. Accrediting retail drug shops to strengthen Tanzania's public health system: an ADDO case study. J Pharm Policy Pract. 2015 Sep 25;8:23. doi: 10.1186/s40545-015-0044-4. eCollection 2015.
- Background: PubMed 30028307Sieverding M, Schatzkin E, Shen J, Liu J. Bias in Contraceptive Provision to Young Women Among Private Health Care Providers in South West Nigeria. Int Perspect Sex Reprod Health. 2018 Mar 1;44(1):19-29. doi: 10.1363/44e5418.
- Derived from this study: PubMed 38851225Mnyippembe A, Sheira LA, McCoy SI, Njau PF, Packel LJ, Hassan K, Solorzano-Barrera C, Maokola W, Kang Dufour MS, Sabasaba A, Liu J. Supporting young women's health through girl-friendly drug vendors in Lake Zone, Tanzania: protocol for the AmbassADDOrs for Health cluster-randomised controlled trial. BMJ Open. 2024 Jun 8;14(6):e078755. doi: 10.1136/bmjopen-2023-078755.
- Individual participant dataSharing planned: Yes. The investigators will make the data and associated documentation available to users upon request and only under a data-sharing agreement with the study team that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying the data after analyses are completed.
Related trials for HIV Infections
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Jenny X Liu, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loyalty card program at drug shops & supply of HIVST and SRH products and Comparison drug shops in people with HIV Infections, run by University of California, San Francisco at 2 sites in Tanzania.
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 4 inclusion and 0 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: stopped early, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative HIV Diagnoses Among 15-24 Year Old Females (time frame: 12-15 months). The study lists 2 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 NCT05357144, which also lists 7 linked publications.
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 20 Aug 2026.