Zambia Healthy Choices Project for Emerging Adults Living With HIV

NCT06415357 | Active Not Recruiting DMC

• 2 other identifiers: STUDY000014961R34DA059935
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

This project will develop and implement a multi-component intervention using mobile health technology to improve HIV self-management and reduce substance use. Specifically, the investigators will adapt Healthy Choices (HC) to develop mobile HC (mHC) and develop Motivational text messaging (MTM) for Zambian emerging adults living with HIV.

Conditions

Pre-Exposure Prophylaxis

Keywords

Pre-Exposure Prophylaxis (PrEP); HIV Prevention; mHealth

Outcome Measures

Primary Outcomes (12)

• Intervention Acceptability: System Usability Score (SUS)

  SUS is a 10-item, 5-point Likert scale for subjective assessment of usability. Each item ranges from 1 to 5. Depending on the item, the score is calculated by subtracting either one from the user response or the user response from 5. Then, the score for each item will be summed and multiplied by 2.5 for the total score. The overall SUS scores range from 0 to 100. A score of \> 50 indicates that the technology-based interventions are acceptable.

  Month 3

• Intervention Acceptability: System Usability Score (SUS)

  SUS is a 10-item, 5-point Likert scale for subjective assessment of usability. Each item ranges from 1 to 5. Depending on the item, the score is calculated by subtracting either one from the user response or the user response from 5. Then, the score for each item will be summed and multiplied by 2.5 for the total score. The overall SUS scores range from 0 to 100. A score of \> 50 indicates that the technology-based interventions are acceptable.

  Month 6

• Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)

  CSQ-8 is an 8-item, 4-point Likert scale measuring the construct of global intervention satisfaction. The total possible composite score ranges from 8 to 32, with higher scores indicating greater acceptability.

  Month 3

• Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)

  CSQ-8 is an 8-item, 4-point Likert scale measuring the construct of global intervention satisfaction. The total possible composite score ranges from 8 to 32, with higher scores indicating greater acceptability.

  Month 6

• Intervention Acceptability: Exit Interview

  Participants will be invited to share their experiences with mHC and MTM, including feedback on acceptability, ease of use, suggestions for improvement, and impact on ART adherence and alcohol use reduction.

  Month 3

• Intervention Feasibility: Participant Retention

  Intervention feasibility will be assessed based on participant retention at Month 6. The retention rate can range from 70 to 90%, with a retention rate of over 85% deemed the minimum criterion for feasibility.

  Baseline to Month 6

• Intervention Feasibility: Number of Responses to MTM

  Intervention feasibility will be evaluated by the total number of responses to MTM.

  Baseline to Month 6

• Intervention Feasibility: Number of mHC Sessions Completed

  Intervention feasibility will be evaluated by the number of completed intervention sessions.

  Baseline to Month 6

• ART Adherence: Visual Analog Scale

  ART adherence will be assessed through the Young Adult Adherence Interview via computer-assisted self-interview (CASI) survey, which contains a visual analog scale (VAS) ranging from 0 to 100. Higher percentages on the VAS indicate greater adherence to ART.

  Baseline, Month 3, and Month 6

• ART Adherence: Self-Reported Adherence

  ART adherence will be evaluated through self-reported adherence over the past four weeks via a CASI survey. Participants will rate their adherence on a scale ranging from 0 to 100%, with higher percentages indicating better adherence to ART.

  Baseline, Month 3, and Month 6

• ART Adherence: Dried Blood Spot (DBS) Testing

  ART adherence will be evaluated by examining the HIV viral load in DBS. Maintaining a viral load of less than 200 copies/ml will indicate adherence to ART.

  Baseline, Month 3, and Month 6

• Alcohol Use: The Timeline Followback (TLFB) Interview

  Alcohol use will be assessed using the TLFB interview. Using a calendar, participants will be asked to provide estimates of their daily drinking over the last 30 days, as well as the max number of drinks in a one-week period, the number of heavy drinking days, the number of standard drinks in 30 days, and binge drinking.

  Baseline, Month 3, and Month 6

Secondary Outcomes (12)

• Information: HIV Knowledge

  Baseline, Month 3, and Month 6

• Information: ART Knowledge

  Baseline, Month 3, and Month 6

• Motivation: Rollnick's Readiness Ruler

  Baseline, Month 3, and Month 6

• Motivation: Decisional Balance for Problem Behavior

  Baseline, Month 3, and Month 6

• Behavioral Skills: Self-Efficacy

  Baseline, Month 3, and Month 6

Study Arms (4)

Standard ART counseling, mHC, and MTM

EXPERIMENTAL

Participants in this arm will receive standard ART counseling, followed by two mHealth interventions (mHC and MTM) to improve PrEP uptake and adherence.

Behavioral: Mobile Healthy Choices (mHC); Behavioral: Motivational Text Messaging (MTM); Behavioral: Standard ART Counseling

Standard ART counseling and mHC

EXPERIMENTAL

Participants in this arm will receive standard ART counseling, followed by one mHealth intervention (mHC) to improve PrEP uptake and adherence.

Behavioral: Mobile Healthy Choices (mHC); Behavioral: Standard ART Counseling

Standard ART counseling and MTM

EXPERIMENTAL

Participants in this arm will receive standard ART counseling, followed by one mHealth intervention (MTM) to improve PrEP uptake and adherence.

Behavioral: Motivational Text Messaging (MTM); Behavioral: Standard ART Counseling

Standard ART counseling

ACTIVE COMPARATOR

Participants in this arm will receive standard ART counseling.

Behavioral: Standard ART Counseling

Interventions

Motivational Text Messaging (MTM) BEHAVIORAL

Text messages with motivational statements will be sent to participants based on their readiness to change, as assessed during mHC session 1. The statements promoting HIV self-management and alcohol use reduction will be derived from an MTM library written by Zambian young people living with HIV. MTM will be delivered to participants daily for two months and weekly for an additional four months at a time that a participant prefers.

Standard ART counseling and MTM; Standard ART counseling, mHC, and MTM

Standard ART Counseling BEHAVIORAL

All participants will receive one-on-one, face-to-face in clinic. Standard ART counseling includes the management and treatment of HIV, reproductive health, substance abuse, and mental health. They will also be counseled about treatment adherence and side-effect management.

Standard ART counseling; Standard ART counseling and MTM; Standard ART counseling and mHC; Standard ART counseling, mHC, and MTM

Mobile Healthy Choices (mHC) BEHAVIORAL

mHC is a four-session computer-delivered intervention based on the Information-Motivation-Behavioral (IMB) model and socioecological model (SEM). Using motivational interviewing, it tailors content to participants' responses. Sessions 1 and 2 focus on HIV self-management and alcohol reduction, gauging importance, confidence, and goals. Strengths, barriers, resources, and strategies are explored. Sessions 3 and 4 review goals, reinforce importance, confidence, and motivation, and strategize behavior maintenance. Over two months, participants engage in goal-oriented sessions, promoting sustained behavior change.

Standard ART counseling and mHC; Standard ART counseling, mHC, and MTM

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 24 years
• Report visual analogue scale showing \<80% medication adherence in the last month AND problematic/risky alcohol use in the last month
• Speak English, Nyanja, or Bemba

You may not qualify if:

• Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
• currently enrolled in another HIV intervention study

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Zambia: collaborator

Study Sites (1)

University of Zambia

Lusaka, Zambia

Location

Related Publications (19)

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  PMID: 27931753 BACKGROUND

• Nabukeera-Barungi N, Elyanu P, Asire B, Katureebe C, Lukabwe I, Namusoke E, Musinguzi J, Atuyambe L, Tumwesigye N. Adherence to antiretroviral therapy and retention in care for adolescents living with HIV from 10 districts in Uganda. BMC Infect Dis. 2015 Nov 14;15:520. doi: 10.1186/s12879-015-1265-5.

  PMID: 26573923 BACKGROUND

• St Clair-Sullivan N, Mwamba C, Whetham J, Bolton Moore C, Darking M, Vera J. Barriers to HIV care and adherence for young people living with HIV in Zambia and mHealth. Mhealth. 2019 Sep 30;5:45. doi: 10.21037/mhealth.2019.09.02. eCollection 2019.

  PMID: 31620472 BACKGROUND

• Williams EC, Hahn JA, Saitz R, Bryant K, Lira MC, Samet JH. Alcohol Use and Human Immunodeficiency Virus (HIV) Infection: Current Knowledge, Implications, and Future Directions. Alcohol Clin Exp Res. 2016 Oct;40(10):2056-2072. doi: 10.1111/acer.13204. Epub 2016 Sep 22.

  PMID: 27696523 BACKGROUND

• Denison JA, Packer C, Stalter RM, Banda H, Mercer S, Nyambe N, Katayamoyo P, Mwansa JK, McCarraher DR. Factors Related to Incomplete Adherence to Antiretroviral Therapy among Adolescents Attending Three HIV Clinics in the Copperbelt, Zambia. AIDS Behav. 2018 Mar;22(3):996-1005. doi: 10.1007/s10461-017-1944-x.

  PMID: 29103190 BACKGROUND

• Tarantino N, Lowery A, Brown LK. Adherence to HIV Care and Associated Health Functioning among Youth Living with HIV in Sub-Saharan Africa. AIDS Rev. 2020 Jul 8;22(2):93-102. doi: 10.24875/AIDSRev.20000101.

  PMID: 32180589 BACKGROUND

• Scott-Sheldon LA, Carey KB, Cunningham K, Johnson BT, Carey MP; MASH Research Team. Alcohol Use Predicts Sexual Decision-Making: A Systematic Review and Meta-Analysis of the Experimental Literature. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S19-39. doi: 10.1007/s10461-015-1108-9.

  PMID: 26080689 BACKGROUND

• Hendershot CS, Stoner SA, Pantalone DW, Simoni JM. Alcohol use and antiretroviral adherence: review and meta-analysis. J Acquir Immune Defic Syndr. 2009 Oct 1;52(2):180-202. doi: 10.1097/QAI.0b013e3181b18b6e.

  PMID: 19668086 BACKGROUND

• Mulawa MI, LeGrand S, Hightow-Weidman LB. eHealth to Enhance Treatment Adherence Among Youth Living with HIV. Curr HIV/AIDS Rep. 2018 Aug;15(4):336-349. doi: 10.1007/s11904-018-0407-y.

  PMID: 29959649 BACKGROUND

• Doyle AM, Bandason T, Dauya E, McHugh G, Grundy C, Dringus S, Dziva Chikwari C, Ferrand RA. Mobile Phone Access and Implications for Digital Health Interventions Among Adolescents and Young Adults in Zimbabwe: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2021 Jan 13;9(1):e21244. doi: 10.2196/21244.

  PMID: 33439136 BACKGROUND

• Ramsey SE, Ames EG, Uber J, Habib S, Clark S, Waldrop D. A Preliminary Test of an mHealth Facilitated Health Coaching Intervention to Improve Medication Adherence among Persons Living with HIV. AIDS Behav. 2021 Nov;25(11):3782-3797. doi: 10.1007/s10461-021-03342-5. Epub 2021 Jun 12.

  PMID: 34117965 BACKGROUND

• Cooper V, Clatworthy J, Whetham J, Consortium E. mHealth Interventions To Support Self-Management In HIV: A Systematic Review. Open AIDS J. 2017 Nov 21;11:119-132. doi: 10.2174/1874613601711010119. eCollection 2017.

  PMID: 29290888 BACKGROUND

• Hutton A, Prichard I, Whitehead D, Thomas S, Rubin M, Sloand E, Powell TW, Frisch K, Newman P, Goodwin Veenema T. mHealth Interventions to Reduce Alcohol Use in Young People: A Systematic Review of the Literature. Compr Child Adolesc Nurs. 2020 Sep;43(3):171-202. doi: 10.1080/24694193.2019.1616008. Epub 2019 Jun 13.

  PMID: 31192698 BACKGROUND

• Garofalo R, Kuhns LM, Hotton A, Johnson A, Muldoon A, Rice D. A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults. AIDS Behav. 2016 May;20(5):1049-59. doi: 10.1007/s10461-015-1192-x.

  PMID: 26362167 BACKGROUND

• Suffoletto B, Chung T, Muench F, Monti P, Clark DB. A Text Message Intervention with Adaptive Goal Support to Reduce Alcohol Consumption Among Non-Treatment-Seeking Young Adults: Non-Randomized Clinical Trial with Voluntary Length of Enrollment. JMIR Mhealth Uhealth. 2018 Feb 16;6(2):e35. doi: 10.2196/mhealth.8530.

  PMID: 29453191 BACKGROUND

• Horvath KJ, Smolenski D, Amico KR. An empirical test of the information-motivation-behavioral skills model of ART adherence in a sample of HIV-positive persons primarily in out-of-HIV-care settings. AIDS Care. 2014 Feb;26(2):142-51. doi: 10.1080/09540121.2013.802283. Epub 2013 Jun 3.

  PMID: 23724908 BACKGROUND

• Amico KR, Barta W, Konkle-Parker DJ, Fisher JD, Cornman DH, Shuper PA, Fisher WA. The information-motivation-behavioral skills model of ART adherence in a Deep South HIV+ clinic sample. AIDS Behav. 2009 Feb;13(1):66-75. doi: 10.1007/s10461-007-9311-y. Epub 2007 Sep 18.

  PMID: 17876697 BACKGROUND

• Naar-King S, Outlaw AY, Sarr M, Parsons JT, Belzer M, Macdonell K, Tanney M, Ondersma SJ; Adolescent Medicine Network for HIV/AIDS Interventions. Motivational Enhancement System for Adherence (MESA): pilot randomized trial of a brief computer-delivered prevention intervention for youth initiating antiretroviral treatment. J Pediatr Psychol. 2013 Jul;38(6):638-48. doi: 10.1093/jpepsy/jss132. Epub 2013 Jan 28.

  PMID: 23359664 BACKGROUND

• Murphy DA, Chen X, Naar-King S, Parsons JT; Adolescent Trials Network. Alcohol and marijuana use outcomes in the Healthy Choices motivational interviewing intervention for HIV-positive youth. AIDS Patient Care STDS. 2012 Feb;26(2):95-100. doi: 10.1089/apc.2011.0157. Epub 2011 Dec 22.

  PMID: 22191456 BACKGROUND

Study Officials

• Bo Wang, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: April 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wises to access the data.

Locations

ZA (1)