HIV infection is among the top 10 causes of death in Black women for whom new infection rates are 20 times that of white women. Most HIV infections in women are heterosexually transmitted. High risk sex scripts promote unprotected sex to fulfill relationship needs. We propose to evaluate efficacy of the Guide Enhanced Love, Sex, and Choices (GELSC), an online 12-episode soap opera video series with a new core component; a video guide who addresses viewers at the close of Love, Sex, and Choices (LSC) episodes. The original LSC soap opera video intervention was created to reduce HIV sex risk in urban women. The 20 minute LSC episodes portray women facing relationship dilemmas in high risk situations. The heroines transform self- behavior by awareness of their value, choices, and potential. In a RCT, unprotected sex with high risk partners dropped dramatically (p < 0.001) among those who watched LSC; 19% greater than an HIV prevention text intervention, but the group difference was not statistically significant. The LSC soap opera series was popular; viewers wanted it to continue. Good story telling constructs a landscape of action, (i.e. LSC); and one of consciousness (the guide) offering the viewer access to what those involved in the action know or do not know. Using a mindfulness approach, the new video guide directly addresses viewers, delivering epilogues that build on identification with characters, to move viewers towards new understanding. A pilot study supported this potential effect.
AIM 1 is a RCT to evaluate effect of GELSC on HIV sex risk behavior compared to LSC and to an attention control. The primary outcome is change in unprotected sex with high risk partners (USR) score from the baseline to 6 months post intervention. This study also expands the original LSC study delivery by streaming video to women on their smartphones/computers. Recruiting Black women on-line for HIV prevention research is understudied. This study compares Facebook (FB) to on the ground recruitment to see if online recruitment accesses subgroups who do not respond to conventional recruitment. Pilot data found large numbers of Black women at high risk responded to FB ads on smartphones/ computers, whom were efficiently screened, enrolled, and retained. The following hypotheses will be tested in a RCT in predominately young urban Black women 1) The GELSC treatment arm will show lower frequency of USR compared to the original LSC, 2) both GELSC and LSC arms will show greater reduction in USR than an attention control arm.
AIM 2 compares the enrollment, engagement, retention, risk behaviors, and demographics of high risk, mostly Black women recruited online to those obtained by conventional recruitment. We will compare retention by recruitment method and by site within method. These analyses will show whether there are differences in: 3) reach (enrollment, engagement, demographics, risk) by FB versus conventional recruitment and, 4) if retention of at risk women recruited by FB will be similar to those recruited conventionally. If effective, full GELSC implementation would have broad reach to individuals with Internet access.
This study tests a 12-episode Internet-based, guide enhanced HIV prevention soap opera video series for smartphones or computers, in a randomized clinical trial among predominately African American urban women. If effective, this video intervention could be rapidly implemented and brought to scale at low cost via the Internet, widely reaching young urban women.
|Hu, Yirui; Hoover, Donald R (2016) Non-randomized and randomized stepped-wedge designs using an orthogonalized least squares framework. Stat Methods Med Res :|