Clinical trial NCT02729337: Affecting the Epidemiology of HIV in Uganda
Official title: Affecting the Epidemiology of HIV in Uganda Through Older Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Abstinence
HIV
Contraceptive Usage
Keywords: technology
adolescent
developing country
hiv prevention
mHealth
Lead sponsor: Center for Innovative Public Health Research
Sponsor class: OTHER
Collaborators: name: Internet Solutions for Kids Uganda
First posted: 2016-04-06
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Program feasibility: Recruitment
timeFrame: 24 weeks
measure: Program feasibility: Retention
timeFrame: Through study completion, an average of 6 weeks
measure: Program acceptability as assessed by a scale created for the RCT
timeFrame: At intervention end, 6-weeks post baseline
Secondary outcomes:
measure: Percent of participants reporting condom use during sex as assessed by self-report
timeFrame: At intervention end, 6-weeks post baseline
measure: Percent of participants reporting abstinence as assessed by self-report
timeFrame: At intervention end, 6-weeks post baseline
measure: Percent of participants who have gotten an HIV test as assessed by self-report
timeFrame: At intervention end, 6-weeks post baseline
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Internet Solutions for Kids Uganda
Study officials:
affiliation: Center for Innovative Public Health Research
name: Michele Ybarra, MPH PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ybarra ML, Agaba E, Nyemara N. A Pilot RCT Evaluating InThistoGether, an mHealth HIV Prevention Program for Ugandan Youth. AIDS Behav. 2021 Oct;25(10):3437-3448. doi: 10.1007/s10461-021-03237-5. Epub 2021 May 7.