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Phase 1 N=53 Randomized Single-blind Treatment

Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV

HIV/AIDS

Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Adherence Rate — 20; 17 Participants — p=0.29

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Storytelling Narrative Intervention (Combination_product)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of Massachusetts, Boston
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Adherence Rate
20; 17 0.29
PRIMARY
3-month Abstinence Rate
10; 4
SECONDARY
Self-efficacy in Resisting Smoking Temptation.
35.5; 31.8 0.029 sig

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.

Eligibility Criteria

Inclusion Criteria

women who:

  • are able to speak English
  • self-report HIV infection and submit a supplementary document if necessary
  • are between the ages of 18 and 65
  • have been smoking at least 5 cigarettes a day for the past 6 months
  • own a mobile phone with an access to a video call application such as Skype, Imo, Tango, and Face Time
  • are willing to quit smoking within the next 4 weeks from the baseline assessment; and
  • agree to use an approved form of birth control (e.g., oral medications, condoms, and intrauterine devices) during the study period.

Exclusion Criteria

Women who:

  • are not able to speak English
  • are pregnant or lactating
  • have an active skin disease or serious alcohol use problems (≥ 26 on the Alcohol Use Disorders Identification Test59)
  • self-report currently receiving treatment for a serious mental illness (e.g., schizophrenia and bipolar disorder) or
  • currently use any illegal substances excluding marijuana.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03289676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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