Improving Treatment Adherence and Retention of HIV-Positive Women Through Behavioral Change Interventions Aimed at Their Male Partners: Protocol for a Prospective, Controlled Before-and-After Study (Preprint)

Abstract

BACKGROUND According to the World Health Organization (WHO), in 2018, 37.9 million people were living with HIV (PLWHIV) worldwide. More than two-thirds of PLWHIV live in Sub-Saharan Africa (SSA), where the HIV prevalence in the adult population (aged 15-49) is 3.9%. Furthermore, 1.3 million pregnant women living with HIV, of which 82% received Antiretroviral Therapy (ART) for Prevention of Mother-To-Child Transmission (PMTCT) of HIV. In these countries, one of the challenges is an insufficient level of adherence to treatment, particularly in HIV positive pregnant women. Among the causes, the lack of male partner involvement represents a significant criticality. This issue emerges strongly in Malawi, one of the countries with the highest prevalence of HIV in the world: 9.2% of the adult population living with HIV in 2018. OBJECTIVE The objective of the study is to assess three different interventions aimed at improving adherence and retention to ART therapy among HIV positive women through engagement with their male partners in four Malawian healthcare centres. METHODS The prospective, controlled before-and-after study is articulated in three phases (total 24 months): pre-intervention, intervention and post-intervention analyses. The number of selected clusters (clinical centres) is limited to four, one for each intervention plus a cluster where no intervention will be performed (control arm). The interventions are 1) opening the facility on Saturday a month, only for men, defined "special day"; 2) testing peer-to-peer counselling among men, "male champions"; 3) providing a non-economic incentive to all women accompanied by their partners at the facility, "nudge". The primary outcome of the study is the evaluation of the variations in retention in care and women's adherence to therapeutic protocols; the intermediate outcome is the assessment of the variations in Male Involvement (MI). The level of MI in the health of female partners (intermediate outcome) will be evaluated through a dedicated questionnaire administered at baseline and in the post-intervention phase. Data will be collected at the clinical centres and stored in two electronic databases managed through two different types of software. RESULTS Analysis of data collected in the four centres during the pre-intervention phase is on-going as the enrolment is stopped 31st March 2020. Total patients enrolled are 452 (133 Namandanje: 133, Kapeni: 78, Kapire: 75, Balaka: 166). Meantime, several meetings are performed in the centres to organize the intervention phase. CONCLUSIONS The study will identify the best intervention to involve male partners in women's health according to an approach based on a broad spectrum of behaviours. An important issue is represented by educational tools focused on messages to initiate a reflective discussion of stereotypes and false beliefs related to the idea of masculinity in Malawian culture. CLINICALTRIAL Being a Non-randomised study trial registration is not required. However the registration progress is ongoing and all information will be provided when available