Trial Outcomes & Findings for A Mobile Phone Game to Prevent HIV Among Young Africans (NCT NCT03054051)

NCT ID: NCT03054051

Last Updated: 2019-10-17

Results Overview

To evaluate the feasibility of conducting a technology based intervention in a low resource area, the number of eligible individuals who were interested in participating after hearing about the study was examined. Letters were sent to 150 families inviting them to attend an informational meeting and 126 attended a meeting and were assess for eligibility.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Month 1
• Results posted on: 2019-10-17

Participant Flow

Participants were recruited from schools in Kisumu Town, western Kenya, Africa. Enrollment of participants occurred between March 20, 2017 and April 7, 2017. All study activities were completed by June 19, 2017.

Letters were sent to 150 parent of age-eligible children inviting them to attend informational meetings. Of the 126 who attended a meeting, 90 were interested and eligible to participate and 60 of these were randomly selected to enroll in the study.

Participant milestones

Measure	Tumaini Mobile Phone Game Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.	Standard of Care Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Tumaini Mobile Phone Game n=30 Participants Participants randomized to this arm were invited to play the Tumaini game. Participants were asked to play the game for at least one hour per day for 16 days.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.	Total n=60 Participants Total of all reporting groups
Age, Continuous	12.8 years STANDARD_DEVIATION 1 • n=30 Participants	12.6 years STANDARD_DEVIATION 1 • n=30 Participants	12.7 years STANDARD_DEVIATION 1 • n=60 Participants
Sex: Female, Male Female	14 Participants n=30 Participants	16 Participants n=30 Participants	30 Participants n=60 Participants
Sex: Female, Male Male	16 Participants n=30 Participants	14 Participants n=30 Participants	30 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Kenya	30 Participants n=30 Participants	30 Participants n=30 Participants	60 Participants n=60 Participants

PRIMARY outcome

Timeframe: Month 1

Population: This analysis includes all of the individuals who expressed interest in the study by attending an informational meeting.

To evaluate the feasibility of conducting a technology based intervention in a low resource area, the number of eligible individuals who were interested in participating after hearing about the study was examined. Letters were sent to 150 families inviting them to attend an informational meeting and 126 attended a meeting and were assess for eligibility.

Outcome measures

Measure	All Study Participants n=126 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Number Interested in Participating Uninterested	2 Participants	—
Number Interested in Participating Did not meet inclusion criteria	34 Participants	—
Number Interested in Participating Eligible and interested	90 Participants	—

PRIMARY outcome

Timeframe: Month 1

The number of days needed to recruit 60 participants.

Outcome measures

Measure	All Study Participants n=60 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Time to Recruitment of 60 Participants	18 days	—

PRIMARY outcome

Timeframe: Duration of Study (Up to 4 Months)

The number of participants who consented to participate but then later could not be reached prior to completing all study visits.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Number of Participants Lost to Follow Up	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Duration of Study (Up to 4 Months)

The number of participants who completed all study visits after providing consent are presented here.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Number of Participants Completing the Study	30 Participants	30 Participants

PRIMARY outcome

Timeframe: Month 2

The phone retention rate (phones not lost during the intervention) was assessed by the number of phones returned at the end of the intervention.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Number of Phones Returned	30 phones	—

PRIMARY outcome

Timeframe: Day 17 (post-intervention)

Population: This analysis includes participants in the intervention arm.

Game acceptability was assessed by asking participants how fun playing the game was. The number of participants reporting that the game was "very fun" are presented here.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Number Reporting Game Was Very Fun	27 Participants	—

PRIMARY outcome

Timeframe: Day 17 (post-intervention)

Population: This analysis includes participants randomized to the intervention arm.

The value of the game was assessed with several questions regarding how much the participants learned and how useful the information is. The number of participants reporting that they learned a lot, found the information very useful now, and found the information very useful for the future, are presented below.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Number Reporting the Game is Valuable Learned A Lot	30 Participants	—
Number Reporting the Game is Valuable Information Very Useful Now	29 Participants	—
Number Reporting the Game is Valuable Information Very Useful for Future	30 Participants	—

PRIMARY outcome

Timeframe: Day 17 (post-intervention)

Personal safety associated with being in possession of the phone was assessed by the post-intervention survey. Phones provided for the intervention were set up so that all other features were blocked and only function the phone could perform was playing the game.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Number of Participants Feeling Very Safe	29 Participants	—

PRIMARY outcome

Timeframe: Day 17 (post-intervention)

Population: Only participants randomized to the intervention arm are included in this analysis.

Participants were asked to play the game for at least one hour per day for 16 days. The number of participants who reported playing the game everyday and the number of participants who reported playing the game for an hour or more each time are presented here.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Number of Participants Playing the Game Reported played every day	26 Participants	—
Number of Participants Playing the Game Reported played 1 hour or more every time	23 Participants	—

SECONDARY outcome

Timeframe: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Population: One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Knowledge measures will be assessed via Yes/No survey questions and will address puberty, HIV, sexually transmitted infections (STIs), pregnancy, condoms, and alcohol and drugs. Knowledge was assessed with 15 items and responses are coded as 0 or 1. Total scores range from 0 to 15, with higher scores indicating increased knowledge. A positive value for the change from baseline score indicates an increase in knowledge from the baseline assessment.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Change in Knowledge Baseline score	7.33 score on a scale Standard Deviation 2.12	7.93 score on a scale Standard Deviation 1.74
Change in Knowledge Change from baseline immediately post-intervention	4.76 score on a scale Standard Deviation 2.96	0.27 score on a scale Standard Deviation 2.07
Change in Knowledge Change from baseline at 6 weeks post-intervention	3.80 score on a scale Standard Deviation 2.37	0.80 score on a scale Standard Deviation 2.14

SECONDARY outcome

Timeframe: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Population: One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Self-efficacy was assessed via a 3-point Likert scale, and addressed self-efficacy to seek advice about puberty, sex, relationships; to communicate about protected sex; to reject peer, partner and adult pressure to engage in risk behaviors. Self-efficacy was assessed with 9 items which were scored as 0, 0.5 or 1. Total scores ranged from 0 to 9, with higher scores indicating increased self-efficacy. A positive value for the change from baseline score indicates an increase in self-efficacy since the baseline assessment.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Change in Self-Efficacy Baseline score	5.87 score on a scale Standard Deviation 2.03	6.22 score on a scale Standard Deviation 2.41
Change in Self-Efficacy Change from baseline immediately post-intervention	1.95 score on a scale Standard Deviation 1.57	0.47 score on a scale Standard Deviation 1.07
Change in Self-Efficacy Change from baseline at 6 weeks post-intervention	2.03 score on a scale Standard Deviation 1.83	0.63 score on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Population: One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Risk assessment was assessed via a 3-point Likert scale, and addressed perceived risk of certain risk situations/behaviors and of contracting HIV. Risk is assessed with 4 items and responses are coded as 0, 0.5 or 1. Total scores range from 0 to 4, with higher scores indicating increased risk assessment. A positive value for the change from baseline score indicates an increase in assessing risky situations as risky.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Change in Risk Assessment Baseline score	2.67 score on a scale Standard Deviation 1.25	2.45 score on a scale Standard Deviation 1.50
Change in Risk Assessment Change from baseline immediately post-intervention	0.41 score on a scale Standard Deviation 1.17	0.00 score on a scale Standard Deviation 1.23
Change in Risk Assessment Change from baseline at 6 weeks post-intervention	0.52 score on a scale Standard Deviation 0.99	0.07 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Population: One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Behavioral intention was assessed via Yes/No questions. The measure addressed intention to seek advice, to avoid risk situations, and to engage in health protective behaviors. Behavioral intention is assessed with 6 items that are scored as 0 or 1 and total scores range from 0 to 6. Higher scores in indicate more intention to partake in health protective behaviors and a positive value for the change from baseline score indicates a desirable change in intention.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Change in Behavioral Intention Baseline score	4.43 score on a scale Standard Deviation 0.77	4.83 score on a scale Standard Deviation 0.70
Change in Behavioral Intention Change from baseline immediately post-intervention	0.28 score on a scale Standard Deviation 0.86	-0.12 score on a scale Standard Deviation 0.76
Change in Behavioral Intention Change from baseline at 6 weeks post-intervention	0.43 score on a scale Standard Deviation 0.75	-0.15 score on a scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Population: One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Future orientation was assessed via a single multiple-choice question (Yes/No/Maybe) and addressed perceived locus of control. Response is coded as 0, 0.5, or 1 and higher scores indicate greater understanding of future locus of control. A positive value for the change from baseline score indicates a desirable change in scores.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Change in Future Orientation Baseline score	0.86 score on a scale Standard Deviation 0.30	0.90 score on a scale Standard Deviation 0.24
Change in Future Orientation Change from baseline immediately post-intervention	0.05 score on a scale Standard Deviation 0.34	0.10 score on a scale Standard Deviation 0.34
Change in Future Orientation Change from baseline at 6 weeks post-intervention	0.04 score on a scale Standard Deviation 0.31	0.08 score on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Population: One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Perceived social norms were assessed via a 3-point Likert and addressed sex, gender, condoms, and HIV stigma. Social norms were assessed with 6 items that are scored as 0, 0.5, or 1. Total scores range from 0 to 6 with higher scores indicating perception of more desirable social norms. A positive value for the change from baseline scores indicates a desirable change.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Change in Perceived Social Norms Baseline score	3.72 score on a scale Standard Deviation 1.12	3.67 score on a scale Standard Deviation 1.24
Change in Perceived Social Norms Change from baseline immediately post-intervention	0.47 score on a scale Standard Deviation 1.26	-0.07 score on a scale Standard Deviation 1.30
Change in Perceived Social Norms Change from baseline at 6 weeks post-intervention	0.37 score on a scale Standard Deviation 0.37	-0.15 score on a scale Standard Deviation 1.35

SECONDARY outcome

Timeframe: Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention

Population: One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.

Attitudes were assessed via 3-pt Likert survey questions relating to HIV stigma, condoms, sex, gender, and future orientation. Attitudes were assessed with 15 items and responses coded as 0, 0.5, or 1. Total scores ranged from 0 to 15, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score indicates an increase in desirable attitudes.

Outcome measures

Measure	All Study Participants n=30 Participants Study participants who were randomized to either the intervention or control arm.	Standard of Care n=30 Participants Participants randomized to this arm received no intervention beyond the current standard of care for sexual education.
Change in Attitudes Baseline score	9.95 score on a scale Standard Deviation 2.30	9.22 score on a scale Standard Deviation 2.07
Change in Attitudes Change from baseline immediately post-intervention	0.74 score on a scale Standard Deviation 2.13	0.82 score on a scale Standard Deviation 1.95
Change in Attitudes Change from baseline at 6 weeks post-intervention	1.18 score on a scale Standard Deviation 1.82	0.80 score on a scale Standard Deviation 2.25

Adverse Events

Tumaini Mobile Phone Game

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kate Winskell Enger PhD

Emory University

Phone: 404-727-5286

Email: swinske@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place