HIV Clinical Trial
Official title:
Reducing Urban Women's HIV Risk: Soap Opera Videos on Mobile Devices
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.
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.
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