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Affecting the Epidemiology of HIV in Uganda

Affecting the Epidemiology of HIV in Uganda Through Older Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02729337
Enrollment
203
Registered
2016-04-06
Start date
2017-12-06
Completion date
2019-01-18
Last updated
2020-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Usage, HIV, Sexual Abstinence

Keywords

technology, adolescent, developing country, hiv prevention, mHealth

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.

Interventions

BEHAVIORALITG (In This Together)

Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.

Sponsors

Internet Solutions for Kids Uganda
CollaboratorUNKNOWN
Center for Innovative Public Health Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 22 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Program feasibility: Recruitment24 weeksThe number of participants recruited for the RCT (n=200)
Program feasibility: RetentionThrough study completion, an average of 6 weeksThe number of participants that will remain in the study at program end (80%)
Program acceptability as assessed by a scale created for the RCTAt intervention end, 6-weeks post baselineParticipant ratings of program features (e.g., Text Buddy) at intervention end

Secondary

MeasureTime frameDescription
Percent of participants reporting condom use during sex as assessed by self-reportAt intervention end, 6-weeks post baselineThe 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-reportAt intervention end, 6-weeks post baselineThe 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-reportAt intervention end, 6-weeks post baselineThe percent of participants who report, at intervention end, having gotten an HIV test versus not, during the intervention period

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026