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

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          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.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12905-021-01262-z.

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          Most cited references31

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          Women’s Experiences with Oral and Vaginal Pre-Exposure Prophylaxis: The VOICE-C Qualitative Study in Johannesburg, South Africa

          Background In VOICE, a multisite HIV pre-exposure prophylaxis (PrEP) trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF), we explored socio-cultural and contextual factors that influenced participants’ experience of daily vaginal gel and oral tablet regimens in VOICE. Methods In Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41), serial ethnographic interviews (n = 21), or focus group discussions (n = 40). Audiotaped interviews were transcribed, translated, and coded thematically for analysis. Results Of the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support–from partners and significant others–and the relationship tradeoffs entailed by using the products appear to discourage adequate product use. Conclusions Personal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that shaped women’s perceptions of trial participation and experiences with investigational products. Whether these impacted women’s behaviors and may have contributed to ineffective trial results warrants further investigation.
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            Male Partner Influence on Women's HIV Prevention Trial Participation and Use of Pre-exposure Prophylaxis: the Importance of "Understanding".

            There is widespread evidence that male partners influence women's ability and willingness to join HIV prevention trials and to use female-controlled prevention strategies such as microbicide gels. VOICE-C was an ancillary study to the Microbicide Trials Network's VOICE trial at the Johannesburg site that explored social and structural factors influencing women's use of study tablets and vaginal gel. Qualitative data were analyzed from 102 randomly-selected VOICE participants interviewed through in-depth interviews (IDI, n = 41); ethnographic interviews (n = 21) or focus group discussions (FGD, n = 40) and 22 male partners interviewed in 14 IDI and 2 FGD. Male partners' "understanding" pervaded as a central explanation for how male partners directly and indirectly influenced their female partners' trial participation and product use, irrespective of assignment to the gel or tablet study groups. The meaning behind "understanding" in this context was described by both men and women in two important and complementary ways: (1) "comprehension" of the study purpose including biological properties or effects of the products, and (2) "support/agreeability" for female partners being study participants or using products. During analysis a third dimension of "understanding" emerged as men's acceptance of larger shifts in gender roles and relationship power, and the potential implications of women's increased access to biomedical knowledge, services and prevention methods. Despite displays of some female agency to negotiate and use HIV prevention methods, male partners still have a critical influence on women's ability and willingness to do so. Efforts to increase their understanding of research goals, study design and products' mechanisms of action could ameliorate distrust, empower men to serve as product advocates, adherence buddies, and foster greater adherence support for women in situations where it is needed. Strategies to address gender norms and the broader implications these have for female-initiated HIV prevention should likewise be integrated into future research and program activities.
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              A systematic review of intimate partner violence interventions focused on improving social support and/ mental health outcomes of survivors

              Background Intimate partner violence (IPV) is a key public health issue, with a myriad of physical, sexual and emotional consequences for the survivors of violence. Social support has been found to be an important factor in mitigating and moderating the consequences of IPV and improving health outcomes. This study’s objective was to identify and assess network oriented and support mediated IPV interventions, focused on improving mental health outcomes among IPV survivors. Methods A systematic scoping review of the literature was done adhering to PRISMA guidelines. The search covered a period of 1980 to 2017 with no language restrictions across the following databases, Medline, Embase, Web of Science, PROQUEST, and Cochrane. Studies were included if they were primary studies of IPV interventions targeted at survivors focused on improving access to social support, mental health outcomes and access to resources for survivors. Results 337 articles were subjected to full text screening, of which 27 articles met screening criteria. The review included both quantitative and qualitative articles. As the focus of the review was on social support, we identified interventions that were i) focused on individual IPV survivors and improving their access to resources and coping strategies, and ii) interventions focused on both individual IPV survivors as well as their communities and networks. We categorized social support interventions identified by the review as Survivor focused, advocate/case management interventions (15 studies), survivor focused, advocate/case management interventions with a psychotherapy component (3 studies), community-focused, social support interventions (6 studies), community-focused, social support interventions with a psychotherapy component (3 studies). Most of the studies, resulted in improvements in social support and/or mental health outcomes of survivors, with little evidence of their effect on IPV reduction or increase in healthcare utilization. Conclusion There is good evidence of the effect of IPV interventions focused on improving access to social support through the use of advocates with strong linkages with community based structures and networks, on better mental health outcomes of survivors, there is a need for more robust/ high quality research to assess in what contexts and for whom, these interventions work better compared to other forms of IPV interventions.
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                Author and article information

                Contributors
                wagner@rti.org
                Journal
                BMC Womens Health
                BMC Womens Health
                BMC Women's Health
                BioMed Central (London )
                1472-6874
                25 March 2021
                25 March 2021
                2021
                : 21
                : 126
                Affiliations
                [1 ]GRID grid.62562.35, ISNI 0000000100301493, Women’s Global Health Imperative, , RTI International, ; San Francisco, CA USA
                [2 ]GRID grid.11951.3d, ISNI 0000 0004 1937 1135, Wits Reproductive Health and HIV Institute, ; Johannesburg, South Africa
                [3 ]FHI 360, Durham, NC USA
                [4 ]GRID grid.430421.0, Sonke Gender Justice, ; Cape Town, South Africa
                [5 ]GRID grid.62562.35, ISNI 0000000100301493, RTI International, ; 2150 Shattuck Avenue, Suite 800, Berkeley, CA 94704 USA
                Author information
                http://orcid.org/0000-0002-3417-491X
                Article
                1262
                10.1186/s12905-021-01262-z
                7992829
                33766006
                56771289-da38-40c6-8d17-c9df12af8785
                © The Author(s) 2021

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 23 September 2020
                : 11 March 2021
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100009633, Eunice Kennedy Shriver National Institute of Child Health and Human Development;
                Funded by: FundRef http://dx.doi.org/10.13039/100000200, United States Agency for International Development;
                Award ID: AID-OAA-A-15-00032
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000060, National Institute of Allergy and Infectious Diseases;
                Award ID: UM1AI068633
                Award ID: UM1AI068615
                Award ID: UM1AI106707
                Funded by: FundRef http://dx.doi.org/10.13039/100000025, National Institute of Mental Health;
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2021

                Obstetrics & Gynecology
                hiv prevention,microbicides,prep,intimate partner violence,evaluation,south africa

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