CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 53 enrolled
Drug / intervention
Storytelling Narrative Interventioncombination
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03289676
NCT03289676Phase 1Completed

Determining the Feasibility and Acceptability of a Combined Storytelling Narrative Communication and HIV-tailored Smoking Cessation Intervention for Women Living With HIV

University of Massachusetts, Boston·interventional·Posted Sep 21, 2017·Updated Sep 9, 2019

In Brief

A Phase 1 clinical trial evaluating Storytelling Narrative Intervention for HIV/AIDS. Completed, enrolled 53 participants across 1 site.

Detailed Summary

HIV has transformed into a chronic illness due to the advent of effective treatments in the absence of a cure. As a result, the prevalence of non-AIDS defining cancers (NADCs), including lung cancer, has increased three-fold among people living with HIV. NADCs now account for 50% of all cancers among the people. Smoking is one of the major contributing factors to lung cancer and smoking prevalence is substantially higher in this population than the general U.S. population. Smoking prevalence does not differ by gender among people living with HIV. Women of color, particularly African American women represent the majority of women living with HIV (WLHIV) followed by Latinas. WLHIV smoke at a rate almost 3 times higher than that for the general U.S. female population (e.g., 42% vs. 16%). The proposed study has two phases: 1) the development of a storytelling narrative communication (SNC) intervention that will be added to an established HIV-tailored smoking cessation intervention and 2) a two-arm randomized controlled trial (RCT) of the HIV-tailored intervention plus the SNC Intervention compared with the HIV-tailored intervention only. The investigators will develop narrative videos with three to five WLHIV who will be talking about their personal struggles with smoking and success in quitting. Preliminary study revealed that the established HIV-tailored intervention was effective only for short-term (≤ 2 months) abstinence. Many relapsed to smoking between the 2nd and 6th month of quitting. The investigators propose that the SNC intervention will be an effective strategy to sustain their quit efforts for long-term abstinence (≥ 6 months). A total of 60 WLHIV will be recruited and randomly assigned to either the experimental arm (a combination of HIV-tailored and SNC interventions) or the control arm (HIV-tailored intervention only). Specific aims of the study are to 1) Identify SNC intervention components that are rated high in transport and identification for use as an enhancement to an HIV-tailored smoking cessation intervention; 2) Determine the feasibility and acceptability of the SNC intervention for WLHIV by assessing the rate of recruitment and retention for feasibility and the degree of transport and identification for acceptability; and 3) Establish an effect size of HIV-tailored and SNC interventions for smoking cessation in comparison with the HIV-tailored smoking cessation intervention only for WLHIV, for subsequent grant applications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS
CountriesUnited States

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedSep 21, 2017
Enrollment StartSep 6, 2017
Primary CompletionOct 23, 2018
Study CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.8 years ago

Interventions

Storytelling Narrative Interventioncombination

In the first phase, three sections of a video, each for 5-7 minutes will be produced by "Star" story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection.