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NCT03289676 · ClinicalTrials.gov registry record · Phase 1
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
A Phase 1 study, sponsored by University of Massachusetts, Boston.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT03289676 is a Phase 1 study that has completed, run by University of Massachusetts, Boston. The registered enrollment target is 53 participants.
The verdict
NCT03289676, a Phase 1 study, has completed, sponsored by University of Massachusetts, Boston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study 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
Interventions
- COMBINATION_PRODUCT Storytelling Narrative Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2017-09-06 |
| Est. Completion | 2018-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03289676
The ClinicalTrials.gov registry entry for NCT03289676 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Boston, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Storytelling Narrative Intervention is the first listed.
NCT03289676 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03289676 about?
NCT03289676 is a clinical study titled "Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV". 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 amon...
What is the current status of trial NCT03289676?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2017-09-06. Estimated completion is 2018-11-01.
What interventions are being tested in trial NCT03289676?
The interventions under investigation include: Storytelling Narrative Intervention (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03289676?
This trial is sponsored by University of Massachusetts, Boston, which has 18 total clinical trials registered on ClinicalTrials.gov.
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