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.
Highlights
The number of people newly infected with HIV has declined over the past two decades [1], young African women continue to be at risk of HIV and are, one of the few populations that have not benefited from recent declines in HIV incidence [2]
Within the CHARISMA intervention, the Healthy Relationship Assessment Tool (HEART) was intended to assist lay counselors in determining which of several counseling modules and/or referral mechanisms should be offered based on the potential benefits or harms a participant might encounter from using the vaginal ring. (This tool, as a component of the CHARISMA behavioral counseling intervention, would be piloted within the MTN-025/ HOPE trial of the dapivirine vaginal ring.) In this paper, we describe the development, including finalization of construct and item content, and initial validation of the tool
We followed a standard scale development process [25]. This entailed identifying a pool of potential items and underlying constructs that would be theoretically associated with our intended measure; conducting rounds of cognitive interviews to ensure that potential items were salient, easy to understand and to respond to; administering a survey with the refined items and other potentially associated variables to enable exploratory factor analysis and psychometric evaluation of the resulting constructs; and using qualitative data to predict survey scores in a subset of women to further assess construct validity
Summary
The number of people newly infected with HIV has declined over the past two decades [1], young African women continue to be at risk of HIV and are, one of the few populations that have not benefited from recent declines in HIV incidence [2]. While clinical trials of various regimens of oral PrEP have shown moderate to high levels of protection in HIV-discordant couples and men-who-have-sex-with-men (MSM), several phase 3 trials of oral and vaginal PrEP products among African women failed to show evidence of effectiveness [8]. Across these trials, product adherence has been reportedly low [9,10,11]. While reports of social harms, including intimate partner violence (IPV) have been relatively infrequent in PrEP trials, women who reported recent IPV had a higher risk of low adherence than those who reported no IPV or IPV episodes that occurred in the more distant past [22, 23]
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