HIV Clinical Trial
Official title:
Affecting the Epidemiology of HIV in Uganda Through Older Adolescents
The investigators propose to develop a comprehensive, text messaging-based HIV prevention program for Ugandan adolescents 18-22 years of age.
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.
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