Clinical trial NCT02493647: Love, Sex & Choices: A Web Series on Mobile Devices to Reduce Black Women's HIV Risk
Official title: Reducing Urban Women's HIV Risk: Soap Opera Videos on Mobile Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexual Behavior
Women's Role
Risk Behavior
Chlamydia
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2015-07-09
Enrollment: 814
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Frequency of unprotected vaginal or anal sex with perceived high risk male partner
timeFrame: 6 months
measure: Incidence of HIV testing
timeFrame: 6 months
Secondary outcomes:
measure: composite demographic measure
timeFrame: 6 months
measure: Attrition
timeFrame: 6 months
measure: Identification with Character Scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
affiliation: Northeastern University
name: Rachel Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: