Acceptability and feasibility of the CHARISMA counseling intervention to support women’s use of pre-exposure prophylaxis: results of a pilot study

Abstract

Background Women may need or seek male partner approval to safely and consistently use oral antiretroviral pre-exposure prophylaxis (PrEP) or vaginal microbicides. We developed CHARISMA, a counseling intervention to support women’s relationships and their ability to consistently use HIV prevention products. Methods In a pilot study with 95 female participants in Johannesburg, South Africa, lay counselors implemented CHARISMA, assessing participants’ relationship(s) with their male partner(s) and barriers or facilitators to HIV prevention method use, and then providing tailored, interactive counseling. We conducted study participant surveys and clinic staff interviews to evaluate CHARISMA’s feasibility and acceptability. Results The CHARISMA pilot study indicates that a two-session relationship counseling intervention with 6-month follow-up to support women’s ability to safely and effectively use vaginal microbicides was generally acceptable and feasible. Most participants thought CHARISMA was relevant, helpful, and about the right length, and that it had a positive impact on their relationships with their partners and their product use. Staff estimated that the intervention took 1.5–2 h to implement at enrollment and 45 min to an hour for the month 1 visit. They thought that overall CHARISMA was generally feasible to implement. Conclusions Findings from this study suggest several lessons learned that may be relevant to others developing interventions supporting women’s use of oral PrEP or vaginal microbicides. The use of lay counselors instead of nurses to deliver counseling appeared to be successful, but the counselors experienced significant stress from hearing about participants’ traumatic experiences and required emotional support to avoid burnout. Although staff and participants felt that having multiple intervention sessions over time was valuable, a similar level of intensity may not be feasible in other settings. Further research is needed to determine an intervention delivery mode and follow-up period that optimally balances participant needs and clinic resources. Male engagement was a challenge, as it has been in previous studies of vaginal microbicides. Alternative strategies to reach men that do not require them to come to the clinic or rely on their female partners may be more effective.

“You tell him that ‘baby, I am protecting myself’”: Women’s agency and constraint around willingness to use pre-exposure prophylaxis in the Masibambane Study

“…Similarly, the recent Community Health Clinic Model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) found high acceptability and feasibility for a tailored lay counselor PrEP intervention aimed at building agency and safety in women's relationships. 28,29 Women also readily described the challenges posed by male partners and the complexities of disclosing, or even initiating, discussion of PrEP use within a relationship.…”

Integrating Gender-based Violence Screening and Support Into the Research Clinic Setting: Experiences From an HIV Prevention Open-label Extension Trial in Sub-saharan Africa

“…In addition, two process assessment surveys were conducted after SOP implementation, one each with site staff and leadership, to evaluate the SOP implementation process. Thirteen of the 14 HOPE sites implemented the SOP; the last site was participating in a separate study of an integrated PrEP and IPV counseling intervention called the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA), following separate study-specific procedures and SOPs (22,23). The CHARISMA site was included in the needs assessment but did not complete the process evaluation.…”

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

“…TV scales from the tool prior to implementing the effectiveness study. However, interim evaluation of the pilot [31] suggested that the progress of constructs and items in the HEART evoked deeper, yet non-threatening reflection among participants of their relationship with a primary partner. This led us to revise and further study HEART constructs in the upcoming effectiveness study, rather than eliminate immediately.…”

“…From a feasibility perspective, a smaller tool with fewer items would take less time to implement in a busy clinic setting. In an interim assessment of CHARISMA acceptability and feasibility, most participants (61%) felt the tool took the right amount of time, while 25% felt it was too long [31]. On the other hand, some lay counselors noted that the flow of the tool, which moves from more normative items related to gender-based values to partner support, partner abuse and control, resistance towards HIV prevention and finally HIV prevention readiness facilitated participants' ability to think carefully about their current relationship.…”

“…The goal is to ensure that the tool is both sensitive to identifying women who could face partner-related challenges to adherence, but also targeted to those who will benefit from IPV or disclosure modules without distressing clients or overburdening counselors. During the interim assessment, some women felt that they had been incorrectly identified as being at high-risk for IPV and objected to receiving the IPV module [31].…”