NCT05863923

Brief Summary

The intersection of smoking and HIV/AIDS poses a serious public health threat in Vietnam. Vietnam is dealing with these two challenges with parallel rather than integrated plans. Using a computer-tailored texting intervention, study investigators seek to promote the use of an underused, available, government-funded resource (the Quitline) and Nicotine Replacement Therapy (NRT) that the quitline provides, thus, promoting cessation among PLWH.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Apr 2023Aug 2026

First Submitted

Initial submission to the registry

March 31, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

March 31, 2023

Last Update Submit

July 17, 2025

Conditions

Tobacco Cessation

Keywords

mHealth

Outcome Measures

Primary Outcomes (1)

  • Smoking Cessation Rate

    At six months, we will assess 7-day point prevalence cessation, based on the following question: "Do you currently smoke tobacco (smoked even 1 puff in the last 7 days)?" The Society of Nicotine and Tobacco Research has recommended this measure.

    At 6 months post-randomization

Secondary Outcomes (4)

  • Self-Efficacy

    0-month (baseline) and 6-months post-randomization

  • HIV-Related Stigma

    0-month (baseline) and 6-months post-randomization

  • Quitline Use

    6-months post-randomization

  • NRT Use

    6-months post-randomization

Study Arms (2)

Intervention

EXPERIMENTAL

The M2Q2-HIV intervention includes 3 functions: 1) Extended CHW services, 2) M2Q2 computer-tailored peer messaging, and 3) texting facilitation to quitline use and the quitline intervention. Our goals are to promote the use of an underused, available, government-funded resource for public health (quitline) and NRT that the quitline provides, thus promoting smoking cessation among PLWH.

Behavioral: mHealth Messaging to Motivate Quitline use and Quitting among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)

Comparison

ACTIVE COMPARATOR

Comparison smokers will receive five brief "risk of smoking" texts as minimal texting intervention, to enhance blinding to knowledge of randomization group.

Behavioral: M2Q2-HIV Comparison

Interventions

mHealth Messaging to Motivate Quitline use and Quitting among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)BEHAVIORAL

Participants in the intervention group will be exposed to the texting intervention through a series of culturally tailored assessments and motivational text messages from the text messaging system sent throughout the 6 months of duration of the study.

Intervention
M2Q2-HIV ComparisonBEHAVIORAL

Participants in the comparison group will be exposed to a brief set of five texts with facts about smoking risks and assessment messages that are not culturally tailored from the text messaging system.

Comparison

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed HIV infection (prevalent and incident HIV).
  • At least 18 years old.
  • Current smoker.
  • Be able to receive texts and read text (literate).

You may not qualify if:

  • Pregnant or planning to become pregnant during the next six months.
  • Unable or unwilling to provide informed consent.
  • Prior diagnosis of serious mental health illness.
  • Smoker who helped develop the motivational texts used in the intervention (participated in Aim 1).
  • Family member of another participant in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

Institute of Population, Health, and Development (PHAD)

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

  • Rajani S Sadasivam, PhD

    University of Massachusetts Chan Medical School

    PRINCIPAL INVESTIGATOR

  • Hoa T Nguyen, MD, MS, PhD

    University of Massachusetts Chan Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2023

First Posted

May 18, 2023

Study Start

April 17, 2023

Primary Completion

March 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations

US(1)VN(1)