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| ID | Type | Description | Link |
|---|---|---|---|
| 5R33MH124200-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This is a cluster-randomized controlled trial that aims to conduct comprehensive feasibility testing of a smartphone game in a sample of 120 adolescents living with HIV (ALHIV) ages 15-21 in Kisumu, Kenya, to determine whether the game influences behavioral mediators of engagement in care and sexual risk avoidance and reduction (including knowledge, attitudes, behavioral intentions, and self-efficacy).
This is a cluster-randomized feasibility study that will involve clinic-level randomization of 120 ALHIV participants (12 from each of 10 clinical centers). Participants will either use the intervention (a smartphone game) or continue standard treatment and support for HIV. Participants will complete 5 surveys about behaviors, attitudes, knowledge, and self-efficacy relating to engagement in care, ART adherence, and sexual and reproductive health. They will also have blood drawn 3 times to measure their HIV viral load. Intervention-arm participants will also complete app experience surveys. A sample of intervention-arm participants will be invited to provide feedback on their experience in interviews (n=10) and/or focus groups (n=30).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | The intervention is an Android smartphone-based interactive narrative-driven game called MyGoals. Participants will be instructed to play the game for at least 30 minutes for 5 days per week for the first 6 weeks and as desired thereafter. |
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| Control Arm | Active Comparator | Control-arm participants will receive the current standard of care offered at their CCC (i.e. HIV care management support and counselling received at the CCC). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyGoals | Behavioral | A smartphone game for ALHIV aged 15-21 yrs MyGoals includes 3 components:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in knowledge | Knowledge measures will be assessed via Yes/No//I do not know survey questions and will address ART (antiretroviral therapy), 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. Total possible score range is 0-14. A positive value for the change from baseline score will indicate an increase in knowledge from the baseline assessment. | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention |
| Change in attitudes | Attitudes will be assessed via Likert survey questions relating to HIV stigma, condoms, sex, and gender. Attitudes items will be scored on a 0-1 scale, with higher scores indicating more desirable attitudes. Total possible score range is 0-14. A positive value for the change from baseline score will indicate an increase in desirable attitudes. | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention |
| Change in behavioral intentions | Behavioral intention will be assessed via Likert survey questions. The measure will address intention to avoid risk 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. Total possible score range is 0-9. | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention |
| Change in self-efficacy | Self-efficacy will be assessed via a Likert scale, and focus on self-efficacy for condom use; to communicate with a partner about protected sex; to adhere to medication; to fully engage in care and to disclose their HIV status. 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. Total possible score range is 0-23. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in viral load (VL) from baseline | VL will be assessed as "undetectable" (<50 copies/ml) or "detectable". | Baseline, mid-point (around 4 months post-intervention), and endline (9 months post-intervention) |
| Change in attendance at scheduled clinic visits |
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Adolescents, male and female, aged 15-21 in Kisumu County (n=120)
Inclusion criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kate Winskell, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KEMRI Clinical Research Centre | Kisumu | 54840 | Kenya |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2025 | Aug 15, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000294 | Adolescent Behavior |
| D010349 | Patient Compliance |
| D000074822 | Treatment Adherence and Compliance |
| D043762 | Reproductive Behavior |
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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A cluster-randomized feasibility study, that involves clinic-level randomization
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| Standard of care | Behavioral | A minimum standard of care package will be identified prior to identification and recruitment of CCCs to ensure a comparable and adequate level of care is being offered to all control participants, since implementation of the range of support and care strategies recommended by the Kenya Ministry of Health differs by clinic. |
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| Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention |
| Change in game acceptability | Acceptability will be assessed among intervention-arm participants via Likert scale questions. Acceptability will be scored on a 0-1 scale with higher scores indicating higher acceptability. Total possible score range is 0-12, with higher score correlating with better study outcome. | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention |
| Change in game immersion | Immersion will be assessed among intervention-arm participants via Likert scale questions and focus on identification, transportation, and immersion. Immersion items will be scored on a 0-1 scale with higher scores indicating stronger immersion. Total possible score range is 0-18. Higher score correlates with better study outcome. | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention |
| Change in game continued use | Continued use of the intervention over the course of the study will be assessed among intervention-arm participants via both self-report survey questions and analysis of paradata. Survey items will assess self-reported use of the game in hours at each follow-up study timepoint. Paradata analysis will calculate time in hours spent on the app for each intervention-arm participant. | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention |
| Change in game demand | Demand for ongoing access to the intervention following study endline will be assessed among intervention-arm participants via Likert scale questions. Demand items will be scored on a 0-1 scale with higher scores indicating stronger demand. Total possible score range is 0-2, and higher score correlates with better study outcome. | Baseline, 9 months post-intervention |
| Change in game safety | Participants' perceived safety while in possession of the phone and app will be assess among intervention-arm participants via Likert scale questions. These will focus on physical safety as well as comfort with having an HIV-related app on the study phone. Safety items will be scored on a 0-1 scale with higher scores indicating higher perceived safety. Total possible score range is 0-4, and higher score correlates with better study outcome. | Baseline, 6 weeks, 3 months, 6 months and 9 months post-intervention |
Participant medical records (MR) will be used to review attendance. |
| Baseline, 9 months post-intervention |
| Change in Retention in care | Retention in care will be assessed as "disengaged" (has missed the last scheduled appointment and over half of all scheduled appointment within the previous study period) or "engaged". | Baseline, 9 months post-intervention |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D015438 | Health Behavior |