Affecting the Epidemiology of HIV in Uganda

HIV Clinical Trial

Official title:

Affecting the Epidemiology of HIV in Uganda Through Older Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729337
• Other study ID #: MH109296
• Status: Completed
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: January 18, 2019

Study information

• Verified date: February 2020
• Source: Center for Innovative Public Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: January 18, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Usage
• HIV
• Sexual Abstinence

Intervention

Behavioral:
• ITG (In This Together)
Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.

Locations

Country	Name	City	State
Uganda	Internet Solutions for Kids Uganda	Mbarara

Sponsors (2)

Lead Sponsor	Collaborator
Center for Innovative Public Health Research	Internet Solutions for Kids Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program feasibility: Recruitment	The number of participants recruited for the RCT (n=200)	24 weeks
Primary	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
Primary	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	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
Secondary	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
Secondary	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