Pre-Exposure ProphylaxisNCT06415357

Zambia Healthy Choices Project for Emerging Adults Living With HIV

A study testing Mobile Healthy Choices (mHC), Motivational Text Messaging (MTM) and Standard ART Counseling in people with Pre-Exposure Prophylaxis, run by University of Massachusetts, Worcester at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Pre-Exposure Prophylaxis
What is being tested?: Mobile Healthy Choices (mHC), Motivational Text Messaging (MTM) and Standard ART Counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 164 participants
Where: 1 siteZambia
Study dates: 20 Apr 2024to 31 Jul 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Zambia1 site

University of Zambia
Lusaka

Other trials in Zambia

About this study

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

Conditions: Pre-Exposure Prophylaxis
Being tested: Mobile Healthy Choices (mHC), Motivational Text Messaging (MTM), Standard ART Counseling
Keywords: Pre-Exposure Prophylaxis (PrEP), HIV Prevention, mHealth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile Healthy Choices (mHC)Behavioural
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.
Motivational Text Messaging (MTM)Behavioural
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 CounselingBehavioural
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.

Study groups in NCT06415357
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Behavioral: Motivational Text Messaging (MTM); Behavioral: Standard ART Counseling
Standard ART counseling	Active comparator	Participants in this arm will receive standard ART counseling. Receives: Behavioral: Standard ART Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Month 6
Intervention Feasibility: Number of Responses to MTM
Intervention feasibility will be evaluated by the total number of responses to MTM.
Measured: Baseline to Month 6
Intervention Feasibility: Number of mHC Sessions Completed
Intervention feasibility will be evaluated by the number of completed intervention sessions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, and Month 6

Secondary outcomes (12)

Information: HIV Knowledge
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.
Measured: Baseline, Month 3, and Month 6
Information: ART Knowledge
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.
Measured: Baseline, Month 3, and Month 6
Motivation: Rollnick's Readiness Ruler
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.
Measured: Baseline, Month 3, and Month 6
Motivation: Decisional Balance for Problem Behavior
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
Measured: Baseline, Month 3, and Month 6
Behavioral Skills: Self-Efficacy
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.
Measured: Baseline, Month 3, and Month 6
STI Diagnosis: Number of participants who are diagnosed with syphilis, gonorrhea, or chlamydia
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.
Measured: Baseline and Month 6
Sexual Risk
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.
Measured: Baseline, Month 3, and Month 6
Drug Use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
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.
Measured: Baseline, Month 3, and Month 6
Drug Use: Alcohol Use Disorder Identification Text (AUDIT-C)
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.
Measured: Baseline, Month 3, and Month 6
Mental health: Brief Symptom Inventory (BSI-18)
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.
Measured: Baseline, Month 3, and Month 6
Social support: Social Provision Scale
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.
Measured: Baseline, Month 3, and Month 6
HIV stigma: Shortened Version of Berger's Stigma Scale
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.
Measured: Baseline, Month 3, and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 202431 Jul 2026

First posted16 May 2024
Study start20 Apr 2024
Primary completion30 Jun 2026
Study completion31 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06415357
Sponsor's protocol ID: STUDY00001496
Other IDs: 1R34DA059935
Status last verified: Aug 2026
First submitted: 10 May 2024
Last updated: 31 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All IPD collected during the trial, after deidentification.

Publications

Chenneville T, Machacek M, St John Walsh A, Emmanuel P, Rodriguez C. Medication Adherence in 13- to 24-Year-Old Youth Living With HIV. J Assoc Nurses AIDS Care. 2017 May-Jun;28(3):383-394. doi: 10.1016/j.jana.2016.11.002. Epub 2016 Nov 11.
PubMed 27931753
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.
PubMed 26573923
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.
PubMed 31620472
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.
PubMed 27696523
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.
PubMed 29103190
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.
PubMed 32180589
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.
PubMed 26080689
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.
PubMed 19668086
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.
PubMed 29959649
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.
PubMed 33439136
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.
PubMed 34117965
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.
PubMed 29290888
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.
PubMed 31192698
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.
PubMed 26362167
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.
PubMed 29453191

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pre-Exposure Prophylaxis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adapting mHealth Interventions to Improve Self-management of HIV and Substance Use Among Emerging Adults in Zambia
ClinicalTrials.gov ID: NCT06415357
Acronym / sponsor ID: STUDY00001496
Conditions: Pre-Exposure Prophylaxis
Keywords: Pre-Exposure Prophylaxis (PrEP), HIV Prevention, mHealth
Study type: Interventional
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), University of Zambia
Study start: 20 Apr 2024 (actual)
Primary completion: 30 Jun 2026 (actual)
Study completion: 31 Jul 2026 (actual)
First posted: 16 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Standard ART counseling, mHC, and MTM	Experimental	Behavioral: Mobile Healthy Choices (mHC), Behavioral: Motivational Text Messaging (MTM), Behavioral: Standard ART CounselingParticipants in this arm will receive standard ART counseling, followed by two mHealth interventions (mHC and MTM) to improve PrEP uptake and adherence.
Standard ART counseling and mHC	Experimental	Behavioral: Mobile Healthy Choices (mHC), Behavioral: Standard ART CounselingParticipants in this arm will receive standard ART counseling, followed by one mHealth intervention (mHC) to improve PrEP uptake and adherence.
Standard ART counseling and MTM	Experimental	Behavioral: Motivational Text Messaging (MTM), Behavioral: Standard ART CounselingParticipants in this arm will receive standard ART counseling, followed by one mHealth intervention (MTM) to improve PrEP uptake and adherence.
Standard ART counseling	Active comparator	Behavioral: Standard ART CounselingParticipants in this arm will receive standard ART counseling.

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mobile Healthy Choices (mHC)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.	Behavioural	Standard ART counseling and mHC, Standard ART counseling, mHC, and MTM
Motivational Text Messaging (MTM)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.	Behavioural	Standard ART counseling and MTM, Standard ART counseling, mHC, and MTM
Standard ART CounselingAll 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.	Behavioural	Standard ART counseling, Standard ART counseling and MTM, Standard ART counseling and mHC, Standard ART counseling, mHC, and MTM

Primary outcome

Intervention Acceptability: System Usability Score (SUS)
Time frame: Month 3
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.
Intervention Acceptability: System Usability Score (SUS)
Time frame: Month 6
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.
Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)
Time frame: Month 3
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.
Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)
Time frame: Month 6
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.
Intervention Acceptability: Exit Interview
Time frame: Month 3
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.
Intervention Feasibility: Participant Retention
Time frame: Baseline to Month 6
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.
Intervention Feasibility: Number of Responses to MTM
Time frame: Baseline to Month 6
Intervention feasibility will be evaluated by the total number of responses to MTM.
Intervention Feasibility: Number of mHC Sessions Completed
Time frame: Baseline to Month 6
Intervention feasibility will be evaluated by the number of completed intervention sessions.
ART Adherence: Visual Analog Scale
Time frame: Baseline, Month 3, and Month 6
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.
ART Adherence: Self-Reported Adherence
Time frame: Baseline, Month 3, and Month 6
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.
ART Adherence: Dried Blood Spot (DBS) Testing
Time frame: Baseline, Month 3, and Month 6
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.
Alcohol Use: The Timeline Followback (TLFB) Interview
Time frame: Baseline, Month 3, and Month 6
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.

12 secondary outcomes

Information: HIV Knowledge
Time frame: Baseline, Month 3, and Month 6
Information: ART Knowledge
Time frame: Baseline, Month 3, and Month 6
Motivation: Rollnick's Readiness Ruler
Time frame: Baseline, Month 3, and Month 6
Motivation: Decisional Balance for Problem Behavior
Time frame: Baseline, Month 3, and Month 6
Behavioral Skills: Self-Efficacy
Time frame: Baseline, Month 3, and Month 6
STI Diagnosis: Number of participants who are diagnosed with syphilis, gonorrhea, or chlamydia
Time frame: Baseline and Month 6
Sexual Risk
Time frame: Baseline, Month 3, and Month 6
Drug Use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time frame: Baseline, Month 3, and Month 6
Drug Use: Alcohol Use Disorder Identification Text (AUDIT-C)
Time frame: Baseline, Month 3, and Month 6
Mental health: Brief Symptom Inventory (BSI-18)
Time frame: Baseline, Month 3, and Month 6
Social support: Social Provision Scale
Time frame: Baseline, Month 3, and Month 6
HIV stigma: Shortened Version of Berger's Stigma Scale
Time frame: Baseline, Month 3, and Month 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
Background: PubMed 27931753Chenneville T, Machacek M, St John Walsh A, Emmanuel P, Rodriguez C. Medication Adherence in 13- to 24-Year-Old Youth Living With HIV. J Assoc Nurses AIDS Care. 2017 May-Jun;28(3):383-394. doi: 10.1016/j.jana.2016.11.002. Epub 2016 Nov 11.
Background: PubMed 26573923Nabukeera-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.
Background: PubMed 31620472St 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.
Background: PubMed 27696523Williams 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.
Background: PubMed 29103190Denison 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.
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Individual participant dataSharing planned: Yes. All IPD collected during the trial, after deidentification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bo Wang, PhD principal investigator

University of Massachusetts, Worcester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention Acceptability: System Usability Score (SUS) (time frame: Month 3). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06415357, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.