## Protocol Section
### Identification Module
**NCT ID:** NCT06415357

**Brief Title:** Zambia Healthy Choices Project for Emerging Adults Living With HIV

**Official Title:** Adapting mHealth Interventions to Improve Self-management of HIV and Substance Use Among Emerging Adults in Zambia

#### Organization Study ID Info
**ID:** STUDY00001496
#### Organization
**Class:** OTHER
**Full Name:** University of Massachusetts, Worcester
#### Secondary ID Infos
**ID:** 1R34DA059935
**Link:** https://reporter.nih.gov/quickSearch/1R34DA059935
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-01-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Drug Abuse (NIDA)

**Class:** OTHER

**Name:** University of Zambia

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Massachusetts, Worcester

#### Responsible Party

**Investigator Affiliation:** University of Massachusetts, Worcester

**Investigator Full Name:** Bo Wang

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Pre-Exposure Prophylaxis

**Keywords:**

- Pre-Exposure Prophylaxis (PrEP)

- HIV Prevention

- mHealth

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** FACTORIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Mobile Healthy Choices (mHC)

- Behavioral: Motivational Text Messaging (MTM)

- Behavioral: Standard ART Counseling

**Label:** Standard ART counseling, mHC, and MTM

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Mobile Healthy Choices (mHC)

- Behavioral: Standard ART Counseling

**Label:** Standard ART counseling and mHC

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Behavioral: Motivational Text Messaging (MTM)

- Behavioral: Standard ART Counseling

**Label:** Standard ART counseling and MTM

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Participants in this arm will receive standard ART counseling.

**Intervention Names:**

- Behavioral: Standard ART Counseling

**Label:** Standard ART counseling

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Standard ART counseling and mHC

- Standard ART counseling, mHC, and MTM

**Description:** 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.

**Name:** Mobile Healthy Choices (mHC)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Standard ART counseling and MTM

- Standard ART counseling, mHC, and MTM

**Description:** 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.

**Name:** Motivational Text Messaging (MTM)

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Standard ART counseling

- Standard ART counseling and MTM

- Standard ART counseling and mHC

- Standard ART counseling, mHC, and MTM

**Description:** 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.

**Name:** Standard ART Counseling

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Intervention Acceptability: System Usability Score (SUS)

**Time Frame:** Month 3

**Description:** 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.

**Measure:** Intervention Acceptability: System Usability Score (SUS)

**Time Frame:** Month 6

**Description:** 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.

**Measure:** Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)

**Time Frame:** Month 3

**Description:** 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.

**Measure:** Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)

**Time Frame:** Month 6

**Description:** 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.

**Measure:** Intervention Acceptability: Exit Interview

**Time Frame:** Month 3

**Description:** 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.

**Measure:** Intervention Feasibility: Participant Retention

**Time Frame:** Baseline to Month 6

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

**Measure:** Intervention Feasibility: Number of Responses to MTM

**Time Frame:** Baseline to Month 6

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

**Measure:** Intervention Feasibility: Number of mHC Sessions Completed

**Time Frame:** Baseline to Month 6

**Description:** 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.

**Measure:** ART Adherence: Visual Analog Scale

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** 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.

**Measure:** ART Adherence: Self-Reported Adherence

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** 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.

**Measure:** ART Adherence: Dried Blood Spot (DBS) Testing

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** 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.

**Measure:** Alcohol Use: The Timeline Followback (TLFB) Interview

**Time Frame:** Baseline, Month 3, and Month 6

#### Secondary Outcomes

**Description:** HIV transmission risk awareness will be evaluated through an 18-item HIV Knowledge Questionnaire. Total possible composite scores range from 0 to 18, with higher scores indicating a higher level of HIV knowledge.

**Measure:** Information: HIV Knowledge

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** ART knowledge will be evaluated through a 21-item HIV Treatment Knowledge Questionnaire. Total possible composite scores range from 0 to 21, with higher scores indicating a higher level of ART knowledge.

**Measure:** Information: ART Knowledge

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** Intentions to improve HIV self-management and alcohol consumption behaviors will be evaluated using the 5-item Rollnick's Readiness Ruler. Each item ranges from 0 to 10, with higher scores indicating a greater readiness for change.

**Measure:** Motivation: Rollnick's Readiness Ruler

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** Attitudes toward risk behaviors will be assessed using the 32-item Decisional Balance for Problem Behavior scale. This 5-point Likert scale evaluates the perceived pros and cons of engaging in risk behaviors

**Measure:** Motivation: Decisional Balance for Problem Behavior

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** Behavioral skills in HIV self-management will be assessed using a 5-item adapted version of the Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. This 5-point Likert scale measures confidence levels (score range: 5-25), with higher scores indicating greater confidence in HIV self-management tasks.

**Measure:** Behavioral Skills: Self-Efficacy

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** Syphilis testing will employ a treponemal test with rapid plasma reagin (RPR), while gonorrhea and chlamydia testing will utilize pooled urine, oropharyngeal, and rectal swabs.

**Measure:** STI Diagnosis: Number of participants who are diagnosed with syphilis, gonorrhea, or chlamydia

**Time Frame:** Baseline and Month 6

**Description:** Sexual risk will be assessed using TLFB interview via CASI, capturing sexual behavior over the past 30 days, such as condom usage and the number of sexual partners.

**Measure:** Sexual Risk

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** Drug use will be assessed with ASSIST, which is a questionnaire to identify substance use health risks and disorders, with each item scored from 0 to 12. The total score ranges up to 24, with higher scores indicating greater risk based on current substance use patterns.

**Measure:** Drug Use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** Alcohol use will be assessed by using AUDIT-C to identify individuals with hazardous drinking habits or alcohol use disorders. Each item scores from 0 to 4, with 0 indicating no alcohol consumption. The total score maxes out at 12, with higher scores suggesting greater risks of harm.

**Measure:** Drug Use: Alcohol Use Disorder Identification Text (AUDIT-C)

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** Mental health will be evaluated with BSI-18. This 18-item questionnaire utilizes a 5-point Likert scale to gauge psychological distress. Scores range up to 72, with higher scores indicating a higher level of psychological distress.

**Measure:** Mental health: Brief Symptom Inventory (BSI-18)

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** Social support will be evaluated using the Social Provision Scale. This 5-point Likert scale, 13-item survey assesses the availability of social support, such as emotional, information, and instrumental support, as well as companionship and social isolation. Scores range up to 65, with higher scores indicating more extensive availability of social support.

**Measure:** Social support: Social Provision Scale

**Time Frame:** Baseline, Month 3, and Month 6

**Description:** HIV-related stigma will be evaluated using the 10-item Berger's Stigma Scale. This scale, based on a 4-point Likert scale, assesses the stigma perceived by people living with HIV. The score can range from 10 to 40, with a higher score indicating greater perceived stigma associated with HIV.

**Measure:** HIV stigma: Shortened Version of Berger's Stigma Scale

**Time Frame:** Baseline, Month 3, and Month 6

### Eligibility Module

**Eligibility Criteria:** Zambian emerging adults living with HIV

Inclusion Criteria:

* 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

Exclusion Criteria:

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

**Healthy Volunteers:** True

**Maximum Age:** 24 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** josephmumbazulu@gmail.com

**Name:** Joseph Zulu, PhD

**Phone:** +260771514511

**Role:** CONTACT

**Contact 2:**

**Email:** deogwoon.kim13@umassmed.edu

**Name:** Deogwoon Kim, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Lusaka

**Contacts:**

***Contact 1:***

- **Email:** josephmumbazulu@gmail.com

- **Name:** Joseph Zulu, PhD

- **Phone:** +260771514511

- **Role:** CONTACT

***Contact 2:***

- **Name:** Joseph Zulu, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Zambia

**Facility:** University of Zambia

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** University of Massachusetts, Worcester

**Name:** Bo Wang, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Anyone who wises to access the data.

**Description:** All IPD collected during the trial, after deidentification.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** Immediately following publication. No end date.

### References Module

#### References

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**PMID:** 27931753

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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.

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**Citation:** 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.

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**Citation:** 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.

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## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3777

- Name: Ethanol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
