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

NCT ID: NCT02493647

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

814 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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HIV Sexual Behavior Women's Role Risk Behavior Chlamydia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Love, Sex, & Choices

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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guide enhanced Love, Sex, & Choices

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Northeastern University

OTHER

Sponsor Role lead

Responsible Party

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Rachel Jones, RN, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Locations

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Northeastern University

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1R01NR014632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LSCR012015

Identifier Type: -

Identifier Source: org_study_id

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