HIVNCT04437667
HIV-Prevention Smartphone Game Trial
A study testing Tumaini Mobile Phone Game in people with HIV, run by Emory University at 1 site in Kenya.
Trial summary
This project, funded by the National Institute of Mental Health, will test the efficacy of an electronic game to prevent HIV among African adolescents (aged 12-17), delivered via inexpensive Android smartphones. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Tumaini Mobile Phone Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteKenya
- Study dates
- 12 Oct 2020to Aug 2028
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 12-14 at time of enrollment
- Resident in Kisumu Town, Kenya
- Having basic English literacy (Grade 3-4 on the Flesch-Kincaid Reading Scale, assessed via a short listening and reading comprehension test at enrollment)
- Only one child per family
- Not previously enrolled in formative research or pilot testing of intervention or survey instruments
Who cannot join
- Aged <12 or >14 at time of enrollment
- Not a resident of Kisumu Town, Kenya
- Not having basic English literacy
- Sibling to a child already enrolled in the study
- Previously involved in formative research or pilot testing of intervention or survey instruments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Trial for a Smartphone Game to Prevent HIV Among Young Africans
This project, funded by the National Institute of Mental Health, will test the efficacy of an electronic game to prevent HIV among African adolescents (aged 12-17), delivered via inexpensive Android smartphones. This study involves a sample of 912 young people and 500 of their parents in Kenya's former Nyanza province, where 11.4% of young women and 3% of men ages 15-24 are HIV-infected. This study will be carried out by Emory University and the Kenya Medical Research Institute (KEMRI).
Read the detailed description
The 912 study participants (youth ages 12-14) will be randomized to the intervention or control arm upon completion of the baseline survey. The assignments will be generated with the use of a pseudo-random-number generator with permuted blocks, used to ensure a sex-balanced and age-balanced assignment to each arm. All participants will be given a low-cost (<$40) Android phone on which the study game will be loaded. Intervention arm phones will have app for Tumaini programmed on them, while control arm phones will have a commercially available game to be determined prior to the start of the randomized clinical trial. Preference will be given to a game or other app with educational content, for example, a general knowledge quiz or strategy game. Each app will be standalone and not require data access or connection to the Internet to function. All participants will be invited to play their assigned game for at least 10 hours during the November-December school holiday. While we anticipate that access to smartphones will be widespread at time of roll-out of an efficacious game, this is not yet the case: for the purposes of this study, phones need to be provided in order to ensure consistency of technology and avoid SES bias. All other phone functions aside from the alarm, will be disabled for safety reasons. The game will automatically record the time spent playing and the choices made in the context of gameplay. When returning the phones, all participants will be asked to fill out a form identifying others with whom the game or app was shared and creators of each profile on their study phones.
In line with the preferences expressed by parents during the feasibility test, the phones will be provided to participants during the long November-December school holidays and collected at the end of the holiday. Providing there is no evidence of contamination, participants will (a) keep the phone throughout the long November-December school holiday; and (b) receive the phone, loaded with the game, again during the November-December holidays of the following years.
- Conditions
- HIV
- Being tested
- Tumaini Mobile Phone Game, Control Mobile Phone Game
- Keywords
- HIV, Adolescents, Prevention, Sexually transmitted infections (STIs)
- 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.
Tumaini Mobile Phone GameBehavioural
Tumaini is a scenario-based role-playing game application. Participants will be instructed to engage in a minimum of 10 hours of gameplay over the holiday period each year. The game will automatically collect for analysis data related to participants' in-game behavior, e.g. time spent playing, scores on knowledge-based mini-games, choices made in the narrative game, components to which the player was exposed. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma; and promote parent-child dialogue.
Control Mobile Phone GameBehavioural
Independent gameplay of control game. Total respondent burden: participants will be invited to engage in at least 10 hours of gameplay during each long school holiday (November-December).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Adolescents participants enrolled in the intervention arm will receive the intervention, Tumaini, loaded on a low-cost Android smartphone, during the long November-December school holidays for the first three years of the study. Receives: Behavioral: Tumaini Mobile Phone Game |
| Control Arm | Active comparator | Adolescent participants enrolled in the control arm will receive a commercially available age- and language-appropriate educational game or knowledge quiz loaded on a study-provided low-cost Android smartphone. Receives: Behavioral: Control Mobile Phone Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at first sex
Age at first sex encounter.
Measured: Up to month 46
Percentage of participants reporting condom use at first sex
Percentage of participants reporting condom use at first sex
Measured: Up to month 46
Binary Risk outcome of "risk" vs "low risk"
Binary outcome of "risk" group (experienced sexual debut during the study period without condom use at first sex) vs "low risk" group (not yet experienced sexual debut by the end of the study, or used a condom at sexual debut during the study period).
Measured: Up to month 46
Change in percentage of participants reporting recent sexual activity
For participants reporting previous sexual intercourse, self-report of sexual intercourse since previous behavioral survey.
Measured: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Change in percentage of participants reporting recent condom use
For participants reporting recent sexual activity, self-report of consistent condom use since previous behavioral survey.
Measured: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Change in number of sexual partners
For participants reporting any past sexual activity, number of different sexual partners
Measured: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Change in percentage of participants with recent alcohol and drug use
Percentage of participants that report recent alcohol and drug use.
Measured: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Change in knowledge
Knowledge measures will be assessed via Yes/No survey questions and will address HIV, sexually transmitted infections (STIs), pregnancy, and condoms. Answers to knowledge questions will be coded as 0 or 1, with higher scores indicating more accurate knowledge. A positive value for the change from baseline score indicate an increase in knowledge from the baseline assessment.
Measured: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Change in self-efficacy
Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy to use a condom correctly; to communicate with a partner about protected sex; to reject peer, partner, and adult pressure to engage in risk behaviors; and, for female participants, to manage menstruation. Self-efficacy will be scored on a 0-1 scale with higher scores indicating stronger self-efficacy. A positive value for the change from baseline score will indicate an increase in self-efficacy since the baseline assessment.
Measured: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Change in risk assessment
Risk assessment will be assessed via a Likert scale, and address perceived risk of certain risk situations/behaviors. Risk items will be scored on a 0-1 scale, with higher scores indicating higher risk assessment. A positive value for the change from baseline score will indicate an increase in assessing risky situations as risky.
Measured: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Change in attitudes
Attitudes will be assessed via Likert survey questions relating to puberty, HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score will indicate an increase in desirable attitudes.
Measured: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Change in behavioral intentions
Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk situations and to engage in health protective behaviors. Behavioral intention items will be scored on a 0-1 scale with higher scores indicating more intention to partake in health protective behaviors and a positive value for the change from baseline score indicating an increase in intention to engage in health protective behaviors.
Measured: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Secondary outcomes (3)
Total length of gameplay
Total time playing from game log files
Measured: Months 3,18, 28
Number of participants with new HSV-2 diagnosis
Incidence rates over the course of study of HSV-2 among uninfected participants will be compared by exposure to intervention using Poisson and/or Cox regression methods.
Measured: Months 1 and 46
Number of participants with new HIV diagnosis
Incidence rates over the course of study of HIV among uninfected participants will be compared by exposure to intervention using Poisson and/or Cox regression methods.
Measured: Months 1 and 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start12 Oct 2020
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Why it stopped: Research activities are currently paused waiting for an answer about a renewal proposal to extend the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute
- Responsible party
- Principal investigator, Kate Winskell, Emory University
- Investigators
- Kate Winskell, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437667
- Sponsor's protocol ID
- IRB00108404
- Other IDs
- 1R01MH118982-01
- Status last verified
- Sep 2025
- First submitted
- 16 Jun 2020
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winskell K, Sabben G, Mbeda C, Ondeng'e K, Arego J, Qin H, Goldenberg S, Ndivo R, Komro K, Bednarczyk RA, Lyles RH, Mudhune V. Efficacy of a smartphone game to increase age and condom use at first sex among adolescents in Kenya (Tumaini): a randomised controlled trial. Lancet Child Adolesc Health. 2026 Apr;10(4):273-283. doi: 10.1016/S2352-4642(25)00353-0.
PubMed 41819981Winskell K, Sabben G, Qin H, Mbeda C, Goldenberg S, Ondeng'e K, Ndivo R, Arego J, He X, Bednarczyk RA, Komro K, Lyles RH, Mudhune V. Longitudinal Effects of a Smartphone Game (Tumaini) for HIV Prevention Among Kenyan Adolescents: 45-Month Trajectories of Condom Use-Related Proximal Outcomes From a Randomized Controlled Trial. J Med Internet Res. 2026 Mar 10;28:e83982. doi: 10.2196/83982.
PubMed 41806862Mudhune V, Winskell K, Bednarczyk RA, Ondenge K, Mbeda C, Kerubo E, Ndivo R, Arego J, Morales M, Halliburton B, Sabben G. Sexual behaviour among Kenyan adolescents enrolled in an efficacy trial of a smartphone game to prevent HIV: a cross-sectional analysis of baseline data. SAHARA J. 2024 Dec;21(1):2320188. doi: 10.1080/17290376.2024.2320188. Epub 2024 Feb 22.
PubMed 38388022Mudhune V, Sabben G, Ondenge K, Mbeda C, Morales M, Lyles RH, Arego J, Ndivo R, Bednarczyk RA, Komro K, Winskell K. The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19. JMIR Res Protoc. 2022 Mar 3;11(3):e35117. doi: 10.2196/35117.
PubMed 35030090
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Trial for a Smartphone Game to Prevent HIV Among Young Africans
- ClinicalTrials.gov ID
- NCT04437667
- Acronym / sponsor ID
- IRB00108404
- Conditions
- HIV
- Keywords
- HIV, Adolescents, Prevention, Sexually transmitted infections (STIs)
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Research activities are currently paused waiting for an answer about a renewal proposal to extend the study.
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 18 Jun 2020 (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 project, funded by the National Institute of Mental Health, will test the efficacy of an electronic game to prevent HIV among African adolescents (aged 12-17), delivered via inexpensive Android smartphones. This study involves a sample of 912 young people and 500 of their parents in Kenya's former Nyanza province, where 11.4% of young women and 3% of men ages 15-24 are HIV-infected. This study will be carried out by Emory University and the Kenya Medical Research Institute (KEMRI).
Detailed description
The 912 study participants (youth ages 12-14) will be randomized to the intervention or control arm upon completion of the baseline survey. The assignments will be generated with the use of a pseudo-random-number generator with permuted blocks, used to ensure a sex-balanced and age-balanced assignment to each arm. All participants will be given a low-cost (<$40) Android phone on which the study game will be loaded. Intervention arm phones will have app for Tumaini programmed on them, while control arm phones will have a commercially available game to be determined prior to the start of the randomized clinical trial. Preference will be given to a game or other app with educational content, for example, a general knowledge quiz or strategy game. Each app will be standalone and not require data access or connection to the Internet to function. All participants will be invited to play their assigned game for at least 10 hours during the November-December school holiday. While we anticipate that access to smartphones will be widespread at time of roll-out of an efficacious game, this is not yet the case: for the purposes of this study, phones need to be provided in order to ensure consistency of technology and avoid SES bias. All other phone functions aside from the alarm, will be disabled for safety reasons. The game will automatically record the time spent playing and the choices made in the context of gameplay. When returning the phones, all participants will be asked to fill out a form identifying others with whom the game or app was shared and creators of each profile on their study phones.
In line with the preferences expressed by parents during the feasibility test, the phones will be provided to participants during the long November-December school holidays and collected at the end of the holiday. Providing there is no evidence of contamination, participants will (a) keep the phone throughout the long November-December school holiday; and (b) receive the phone, loaded with the game, again during the November-December holidays of the following years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Tumaini Mobile Phone GameAdolescents participants enrolled in the intervention arm will receive the intervention, Tumaini, loaded on a low-cost Android smartphone, during the long November-December school holidays for the first three years of the study. |
| Control Arm | Active comparator | Behavioral: Control Mobile Phone GameAdolescent participants enrolled in the control arm will receive a commercially available age- and language-appropriate educational game or knowledge quiz loaded on a study-provided low-cost Android smartphone. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 12-14 at time of enrollment
- Resident in Kisumu Town, Kenya
- Having basic English literacy (Grade 3-4 on the Flesch-Kincaid Reading Scale, assessed via a short listening and reading comprehension test at enrollment)
- Only one child per family
- Not previously enrolled in formative research or pilot testing of intervention or survey instruments
Key exclusion criteria (5 listed)
- Aged <12 or >14 at time of enrollment
- Not a resident of Kisumu Town, Kenya
- Not having basic English literacy
- Sibling to a child already enrolled in the study
- Previously involved in formative research or pilot testing of intervention or survey instruments
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 |
|---|---|---|
| Tumaini Mobile Phone GameTumaini is a scenario-based role-playing game application. Participants will be instructed to engage in a minimum of 10 hours of gameplay over the holiday period each year. The game will automatically collect for analysis data related to participants' in-game behavior, e.g. time spent playing, scores on knowledge-based mini-games, choices made in the narrative game, components to which the player was exposed. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma; and promote parent-child dialogue. | Behavioural | Intervention Arm |
| Control Mobile Phone GameIndependent gameplay of control game. Total respondent burden: participants will be invited to engage in at least 10 hours of gameplay during each long school holiday (November-December). | Behavioural | Control Arm |
Primary outcome
Age at first sex
Time frame: Up to month 46
Age at first sex encounter.
Percentage of participants reporting condom use at first sex
Time frame: Up to month 46
Percentage of participants reporting condom use at first sex
Binary Risk outcome of "risk" vs "low risk"
Time frame: Up to month 46
Binary outcome of "risk" group (experienced sexual debut during the study period without condom use at first sex) vs "low risk" group (not yet experienced sexual debut by the end of the study, or used a condom at sexual debut during the study period).
Change in percentage of participants reporting recent sexual activity
Time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
For participants reporting previous sexual intercourse, self-report of sexual intercourse since previous behavioral survey.
Change in percentage of participants reporting recent condom use
Time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
For participants reporting recent sexual activity, self-report of consistent condom use since previous behavioral survey.
Change in number of sexual partners
Time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
For participants reporting any past sexual activity, number of different sexual partners
Change in percentage of participants with recent alcohol and drug use
Time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Percentage of participants that report recent alcohol and drug use.
Change in knowledge
Time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Knowledge measures will be assessed via Yes/No survey questions and will address HIV, sexually transmitted infections (STIs), pregnancy, and condoms. Answers to knowledge questions will be coded as 0 or 1, with higher scores indicating more accurate knowledge. A positive value for the change from baseline score indicate an increase in knowledge from the baseline assessment.
Change in self-efficacy
Time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy to use a condom correctly; to communicate with a partner about protected sex; to reject peer, partner, and adult pressure to engage in risk behaviors; and, for female participants, to manage menstruation. Self-efficacy will be scored on a 0-1 scale with higher scores indicating stronger self-efficacy. A positive value for the change from baseline score will indicate an increase in self-efficacy since the baseline assessment.
Change in risk assessment
Time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Risk assessment will be assessed via a Likert scale, and address perceived risk of certain risk situations/behaviors. Risk items will be scored on a 0-1 scale, with higher scores indicating higher risk assessment. A positive value for the change from baseline score will indicate an increase in assessing risky situations as risky.
Change in attitudes
Time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Attitudes will be assessed via Likert survey questions relating to puberty, HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score will indicate an increase in desirable attitudes.
Change in behavioral intentions
Time frame: Months 1, 3, 6, 9, 12, 17, 22, 25, 30, 34, 37, 42, 46
Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk situations and to engage in health protective behaviors. Behavioral intention items will be scored on a 0-1 scale with higher scores indicating more intention to partake in health protective behaviors and a positive value for the change from baseline score indicating an increase in intention to engage in health protective behaviors.
3 secondary outcomes
Total length of gameplay
Time frame: Months 3,18, 28
Number of participants with new HSV-2 diagnosis
Time frame: Months 1 and 46
Number of participants with new HIV diagnosis
Time frame: Months 1 and 46
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Derived from this study: PubMed 41819981Winskell K, Sabben G, Mbeda C, Ondeng'e K, Arego J, Qin H, Goldenberg S, Ndivo R, Komro K, Bednarczyk RA, Lyles RH, Mudhune V. Efficacy of a smartphone game to increase age and condom use at first sex among adolescents in Kenya (Tumaini): a randomised controlled trial. Lancet Child Adolesc Health. 2026 Apr;10(4):273-283. doi: 10.1016/S2352-4642(25)00353-0.
- Derived from this study: PubMed 41806862Winskell K, Sabben G, Qin H, Mbeda C, Goldenberg S, Ondeng'e K, Ndivo R, Arego J, He X, Bednarczyk RA, Komro K, Lyles RH, Mudhune V. Longitudinal Effects of a Smartphone Game (Tumaini) for HIV Prevention Among Kenyan Adolescents: 45-Month Trajectories of Condom Use-Related Proximal Outcomes From a Randomized Controlled Trial. J Med Internet Res. 2026 Mar 10;28:e83982. doi: 10.2196/83982.
- Derived from this study: PubMed 38388022Mudhune V, Winskell K, Bednarczyk RA, Ondenge K, Mbeda C, Kerubo E, Ndivo R, Arego J, Morales M, Halliburton B, Sabben G. Sexual behaviour among Kenyan adolescents enrolled in an efficacy trial of a smartphone game to prevent HIV: a cross-sectional analysis of baseline data. SAHARA J. 2024 Dec;21(1):2320188. doi: 10.1080/17290376.2024.2320188. Epub 2024 Feb 22.
- Derived from this study: PubMed 35030090Mudhune V, Sabben G, Ondenge K, Mbeda C, Morales M, Lyles RH, Arego J, Ndivo R, Bednarczyk RA, Komro K, Winskell K. The Efficacy of a Smartphone Game to Prevent HIV Among Young Africans: Protocol for a Randomized Controlled Trial in the Context of COVID-19. JMIR Res Protoc. 2022 Mar 3;11(3):e35117. doi: 10.2196/35117.
- Individual participant dataSharing planned: No
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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.
Kate Winskell, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumaini Mobile Phone Game in people with HIV, run by Emory University at 1 site in Kenya.
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 5 inclusion and 5 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: paused, as of the sponsor's last update on 6 Oct 2025. 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 Kenya. 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?
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?
Age at first sex (time frame: Up to month 46). The study lists 12 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 NCT04437667, which also lists 4 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 6 Oct 2025.