Affecting the Epidemiology of HIV in Uganda

Study Overview
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Brief Summary
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The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age.

Detailed Description
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The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age. The guiding theoretical model is the Information-Motivation-Behavioral Skills (IMB) Model of HIV Preventive Behavior. Intervention development will be iterative: In Phase 1, the investigators will identify an intervention content map. Then, online focus groups (FG) will be conduct online with Ugandan young adults (n = 40-80) to confirm program components (e.g., social support via Text Buddy, optimal time of delivery of daily text messages) and saliency of intended program topics. In Phase 2, the investigation team will translate content into a bank of text messages that will be reviewed for comprehensiveness and inclusion of the most pertinent topics. The final pool of messages among Ugandan young adults will be tested in the Content Advisory Council (CAC; n = 30) to assess their reactions to the content, scope, style, and tone of the messages. In Phase 3, the investigators will merge the content with the software program developed to deliver the intervention and then internally conduct a functionality test of the programmed messages. Following, the protocol and program will be tested in a beta test of 20 Ugandan adults. In Phase 4, the investigators will test the intervention in a randomized controlled trial of 200 Ugandan young adults randomly assigned to either the intervention (n = 100) or control (n = 100) arms. The main outcome measures will focus on feasibility (e.g., recruitment and retention rates) and acceptability (e.g., Text Buddy). The primary efficacy outcome measures, measured at 3-months post-intervention, will be: (a) frequency of unprotected sex acts; (b) sustained sexual abstinence, and (c) increased HIV testing rates. Specific Aims are as follows: Specific Aim 1: Design a 6-week text messaging-based HIV prevention and healthy sexuality program for adolescents 18-22 years old. Specific Aim 2: Pilot test the intervention for feasibility and acceptability among 18- to 22-year-old Ugandans. Specific Aim 3: Obtain preliminary data needed for a larger-scale controlled trial services study to examine program efficacy.

Official Title
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Affecting the Epidemiology of HIV in Uganda Through Older Adolescents

Conditions
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HIV, Sexual Abstinence, Contraceptive Usage

Intervention / Treatment
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* Behavioral: ITG (In This Together)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: living in Uganda aged 18-22 years able to read English exclusive owner of a cell phone using text messaging for at least 6 months intended to have the same phone number or the next six months able to access the Internet (to complete online surveys) able to provide informed consent Exclusion Criteria: no other exclusion criteria will be applied

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITG (In This Together)<br>This will be a multi-week behavioral intervention delivered daily via text messaging. Content will be based upon the IMB model of HIV preventive behavior and informed by our formative work. | Behavioral: ITG (In This Together)<br>* Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.<br>|
| No Intervention: Control Group<br>Given the preliminary nature of the intervention development, the control group will be inactive but blinded. They will receive two messages per week encouraging them to make healthy sexual decisions to reduce their HIV risk. Messages will be didactic and not driven by the IMB model. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Program feasibility: Recruitment | The number of participants recruited for the RCT (n=200) | 24 weeks | 
| Program feasibility: Retention | The number of participants that will remain in the study at program end (80%) | Through study completion, an average of 6 weeks | 
| Program acceptability as assessed by a scale created for the RCT | Participant ratings of program features (e.g., Text Buddy) at intervention end | At intervention end, 6-weeks post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of participants reporting condom use during sex as assessed by self-report | The percent of participants who report, at intervention end, using condoms during sex always versus not using condoms at least once, during the intervention period | At intervention end, 6-weeks post baseline | 
| Percent of participants reporting abstinence as assessed by self-report | The percent of participants who report, at intervention end, not having sex versus having sex at least once, during the intervention period | At intervention end, 6-weeks post baseline | 
| Percent of participants who have gotten an HIV test as assessed by self-report | The percent of participants who report, at intervention end, having gotten an HIV test versus not, during the intervention period | At intervention end, 6-weeks post baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, technology, adolescent, developing country, hiv prevention