Affecting the Epidemiology of HIV in Uganda
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|ClinicalTrials.gov Identifier: NCT02729337|
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sexual Abstinence HIV Contraceptive Usage||Behavioral: ITG (In This Together)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Affecting the Epidemiology of HIV in Uganda Through Older Adolescents|
|Actual Study Start Date :||December 6, 2017|
|Actual Primary Completion Date :||January 18, 2019|
|Actual Study Completion Date :||January 18, 2019|
Experimental: ITG (In This Together)
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)
Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.
No Intervention: Control Group
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.
- Program feasibility: Recruitment [ Time Frame: 24 weeks ]The number of participants recruited for the RCT (n=200)
- Program feasibility: Retention [ Time Frame: Through study completion, an average of 6 weeks ]The number of participants that will remain in the study at program end (80%)
- Program acceptability as assessed by a scale created for the RCT [ Time Frame: At intervention end, 6-weeks post baseline ]Participant ratings of program features (e.g., Text Buddy) at intervention end
- Percent of participants reporting condom use during sex as assessed by self-report [ Time Frame: At intervention end, 6-weeks post baseline ]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
- Percent of participants reporting abstinence as assessed by self-report [ Time Frame: At intervention end, 6-weeks post baseline ]The percent of participants who report, at intervention end, not having sex versus having sex at least once, during the intervention period
- Percent of participants who have gotten an HIV test as assessed by self-report [ Time Frame: At intervention end, 6-weeks post baseline ]The percent of participants who report, at intervention end, having gotten an HIV test versus not, during the intervention period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729337
|Internet Solutions for Kids Uganda|
|Principal Investigator:||Michele Ybarra, MPH PHD||Center for Innovative Public Health Research|