LSC: Love, Sex & Choices: A Web Series on Mobile Devices to Reduce Black Women's HIV Risk

Sponsor
Northeastern University (Other)
Overall Status
Completed
CT.gov ID
NCT02493647
Collaborator
National Institute of Nursing Research (NINR) (NIH)
814
1
2
36
22.6

Study Details

Study Description

Brief Summary

This study tests a 12-episode Internet-based, guide enhanced Love, Sex, & Choices (LSC) HIV prevention soap opera video series for smartphones or computers, in a randomized clinical trial among predominately at-risk African American urban women.

The following hypotheses are to be tested: 1) The LSC treatment arm will show lower unprotected sex risk, meaning lower frequency of unprotected sex (vaginal + anal) with high risk partners at 6 months post intervention compared to an attention control arm 2) The LSC treatment arm will show higher participation in HIV testing at 6 months post intervention compared to the control.

If effective, this video intervention could be rapidly implemented and brought to scale at low cost via the Internet, widely reaching young urban women with the goal of reducing HIV risk behavior and increasing HIV testing.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Love, Sex, & Choices
N/A

Detailed Description

Love, Sex, and Choices (LSC) is an engaging 12-episode video series to reduce HIV risk in young, adult predominately Black women. A peer video guide was added to the end of LSC episodes to provoke viewers to question their own sex scripts and consider their own need for change. The investigators propose to conduct a two-arm clinical trial of the guide enhanced LSC impact on reducing unprotected sex with high risk partners and increasing HIV testing in Black women in high HIV prevalence neighborhoods. Undiagnosed HIV is a significant factor fueling the epidemic. The Control is a 12-episode popular web miniseries with a storyline that promotes respectful relationships. A previous online pilot study was conducted to evaluate the guide enhanced LSC acceptability, the feasibility of Facebook® advertising, and streaming the guide enhanced LSC to smartphones. This pilot study indicated 43.6% went for HIV testing within 30 days post viewing. The guide enhanced LSC was associated with sex risk reduction. Recruitment and retention of Black women in online HIV prevention research remain understudied.

AIM 1 is to conduct a RCT to evaluate the effect of the guide enhanced LSC on HIV sex risk behavior compared to a true attention control.

AIM 2 is to evaluate effect of the guide enhanced LSC on HIV testing. AIM 3 is to compare the reach, meaning enrollment, engagement, retention, risk behaviors, and demographics of high risk, young urban Black women recruited online to those obtained by conventional recruitment: with and without research team assistance, to determine whether online recruitment reaches subgroups not reached in conventional recruitment. Data from Facebook© ads, QR codes, site specific URL on flyers, tracking video viewing, retention data, and risk behaviors will help evaluate efforts to reach and retain high risk women.

AIM 4 is to specify a model of the effect of the guide enhanced LSC series on high risk sex scripts and sex risk. Storytelling can promote behavior change but the study of the mechanism of effect is still young, and entertainment-education concepts of effective film are not yet well integrated into HIV prevention science. Identification with film characters and transportation, characterized by emotional and cognitive empathy and merging, are known to mediate cognitive shifts.

The following hypotheses are to be tested in a RCT in predominately young urban Black women [1) The guide enhanced LSC treatment arm will show lower unprotected sex risk, meaning lower frequency of unprotected sex (vaginal + anal) with high risk partners at 6 months post intervention compared to an attention control arm (2) The guide enhanced LSC treatment arm will show higher participation in HIV testing at 6 months post intervention compared to the control. Investigators will learn by secondary analyses, whether (3) there are differences in reach by Facebook© compared to conventional recruitment, and 4) Retention of at risk women recruited online will be similar to those recruited in the field and 5) whether identification and transportation will lower high risk sex scripts as a mediator of lower USR and greater HIV testing.

Study Design

Study Type:
Interventional
Actual Enrollment :
814 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Reducing Urban Women's HIV Risk: Soap Opera Videos on Mobile Devices
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Love, Sex, & Choices

Love, Sex, and Choices (LSC) is an engaging 12-episode video series to reduce HIV risk in young, adult predominately Black women. A peer video guide was added to the end of LSC episodes to provoke viewers to question their own sex scripts and consider their own need for change. Investigators propose to conduct a two-arm clinical trial of guide enhanced LSC impact on reducing unprotected sex with high risk partners and increasing HIV testing in Black women in high HIV prevalence neighborhoods.

Behavioral: Love, Sex, & Choices
Investigators propose to conduct a two-arm clinical trial of guide enhanced LSC impact on reducing unprotected sex with high risk partners and increasing HIV testing in Black women in high HIV prevalence neighborhoods. Undiagnosed HIV is a significant factor fueling the epidemic. Recruitment into the study will be via Facebook or traditional on the ground.
Other Names:
  • guide enhanced Love, Sex, & Choices
  • No Intervention: Attention-Time Control

    The Control is a 12-episode popular web miniseries with a storyline that promotes respectful relationships. time and frequency are matched to the active intervention.

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of unprotected vaginal or anal sex with perceived high risk male partner [6 months]

      test hypothesis that the LSC treatment arm will show lower unprotected sex risk, meaning lower frequency of unprotected sex (vaginal + anal) with high risk partners at 6 months post intervention compared to an attention control arm

    2. Incidence of HIV testing [6 months]

      Test hypothesis that the LSC treatment arm will show higher participation in HIV testing at 6 months post intervention compared to the control

    Secondary Outcome Measures

    1. composite demographic measure [6 months]

      test whether there are differences in demographics between recruitment online on Facebook© compared to conventional recruitment

    2. Attrition [6 months]

      test whether there are differences in those who do not complete the study between recruitment online on Facebook© compared to conventional recruitment

    3. Identification with Character Scale [1 month]

      test whether identification and transportation will lower high risk sex scripts as a mediator of reducing sex risk and increased HIV testing.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 29 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • sexual relationship with a man in previous 3 months

    • speak and read English

    Exclusion Criteria:
    • younger than 18 years old

    • older than 29 years old

    • currently pregnant

    • women who have already participated in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northeastern University Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Northeastern University
    • National Institute of Nursing Research (NINR)

    Investigators

    • Principal Investigator: Rachel Jones, PhD, Northeastern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rachel Jones, RN, PhD, Associate Professor, Northeastern University
    ClinicalTrials.gov Identifier:
    NCT02493647
    Other Study ID Numbers:
    • LSCR012015
    • 1R01NR014632
    First Posted:
    Jul 9, 2015
    Last Update Posted:
    Aug 22, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2019