Development and initial validation of a simple tool to screen for partner support or opposition to HIV prevention product use

Abstract

In HIV prevention trials, male partners have influenced women’s ability to adhere to investigational products, including antiretroviral (ARV) containing vaginal rings. Validated scales can be useful tools to systematically measure complex constructs, such as those related to male partner engagement. Although multiple scales exist to assess physical, psychological and sexual violence within intimate relationships, fewer scales focus on supportive behaviors within these relationships. Our intervention involved development of a Healthy Relationship Assessment Tool (HEART) that assessed both positive and negative aspects of male partner involvement in women’s HIV prevention. We identified and refined 127 potential items, representing intimate partner violence, agency and social support. A structured survey, including potential items and other sociodemographic and behavioral variables was administered to former microbicide trial and non-trial participants. We conducted an exploratory factor analysis (EFA) to identify a reduced set of constructs and items to screen women who might experience social harms or benefits from vaginal ring use. We examined associations between constructs and with other survey variables to assess content and construct validity. In a subset of 10 women who participated in the survey and qualitative interviews, we used qualitative data to predict survey scores. We retained five constructs with theoretical relevance and good-to-strong reliability for the tool, including: Traditional Values; Partner Support; Partner Abuse & Control; Partner Resistance to HIV Prevention; and HIV Prevention Readiness. Predicted associations between HEART constructs, and correspondence between participants’ qualitative data and HEART scores were generally correct, while those between constructs and other sociodemographic variables were more mixed. Initial validation of the HEART tool was promising. The tool will be used during the CHARISMA pilot study at the Johannesburg MTN 025/HOPE site and validated as part of a randomized controlled trial of CHARISMA within a PrEP demonstration project. Beyond clinical trial settings, HEART could assist PrEP or antiretroviral treatment (ART) providers with an easy-to-administer tool to identify risk and tailor risk reduction, empowerment and adherence counseling for microbicides, PrEP or ART related services.

Evidence for use of a healthy relationships assessment tool in the CHARISMA pilot study

“…In our formative study analysis [22], we predicted and confirmed that PAC and PR scales would be positively correlated with measures of IPV and negatively associated with disclosure. Similarly, we found that PS was negatively correlated with IPV measures, but positively correlated with disclosure.…”

“…Furthermore, while all but the HPR scale showed moderate to good psychometric properties across the two studies, only three of the five subscales provided partnership-related information that directly informed the intervention. In fact, the HPR scale continued to be strongly skewed, as identified in our first analysis [22]. Based on these results, we considered eliminating the HPR and…”

“…Eligible women were aged 18 to 40, and either had prior experience as former trial participants (FTPs) in HIV prevention research or were trial-naïve participants (TNPs). While more fully described in a separate manuscript [22], the goal of the formative study was to identify constructs (e.g., partner support, abuse or other dimensions of partner relationships) and items (e.g., the specific questions or statements) that could characterize women's primary relationships and be formalized in a counselor-administered tool to guide various modules offered as part of the CHARISMA intervention. As described in an earlier paper [21], potential items for the tool were drawn from existing index or scale measures of IPV [23][24][25], sexual powerincluding the Sexual Relationship Power Scale [26,27], or partner support and decision-making [28].…”

“…As part of this expansion study, we will address several remaining questions related to HEART. One question is whether it is possible to improve the HPR subscale [22] by revising subscale content or whether the subscale should be removed from HEART. From a feasibility perspective, a smaller tool with fewer items would take less time to implement in a busy clinic setting.…”

“…The initial development and validation of HEART, which was conducted prior to CHA-RISMA pilot study implementation, has been described elsewhere [21,22]. The purpose of this manuscript is to describe the performance and prospective validity of HEART, from which we can infer the tool's utility to screen, monitor and/or intervene on women's relationships within the context of PrEP delivery.…”