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

Primary Purpose

HIV, Sexual Behavior, Women's Role

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Love, Sex, & Choices
Sponsored by
Northeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

18 Years - 29 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Northeastern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Love, Sex, & Choices

Attention-Time Control

Arm 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. 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.

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.

Outcomes

Primary Outcome Measures

Frequency of unprotected vaginal or anal sex with perceived high risk male partner
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
Incidence of HIV testing
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

composite demographic measure
test whether there are differences in demographics between recruitment online on Facebook© compared to conventional recruitment
Attrition
test whether there are differences in those who do not complete the study between recruitment online on Facebook© compared to conventional recruitment
Identification with Character Scale
test whether identification and transportation will lower high risk sex scripts as a mediator of reducing sex risk and increased HIV testing.

Full Information

First Posted
June 24, 2015
Last Updated
August 21, 2019
Sponsor
Northeastern University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT02493647
Brief Title
Love, Sex & Choices: A Web Series on Mobile Devices to Reduce Black Women's HIV Risk
Acronym
LSC
Official Title
Reducing Urban Women's HIV Risk: Soap Opera Videos on Mobile Devices
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northeastern University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexual Behavior, Women's Role, Risk Behavior, Chlamydia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
814 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Love, Sex, & Choices
Arm Type
Experimental
Arm 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. 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.
Arm Title
Attention-Time Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Love, Sex, & Choices
Other Intervention Name(s)
guide enhanced Love, Sex, & Choices
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of unprotected vaginal or anal sex with perceived high risk male partner
Description
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
Time Frame
6 months
Title
Incidence of HIV testing
Description
Test hypothesis that the LSC treatment arm will show higher participation in HIV testing at 6 months post intervention compared to the control
Time Frame
6 months
Secondary Outcome Measure Information:
Title
composite demographic measure
Description
test whether there are differences in demographics between recruitment online on Facebook© compared to conventional recruitment
Time Frame
6 months
Title
Attrition
Description
test whether there are differences in those who do not complete the study between recruitment online on Facebook© compared to conventional recruitment
Time Frame
6 months
Title
Identification with Character Scale
Description
test whether identification and transportation will lower high risk sex scripts as a mediator of reducing sex risk and increased HIV testing.
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Jones, PhD
Organizational Affiliation
Northeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northeastern University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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