WeMen! Improving Women's Access to Healthcare System Through Men's Inclusion

Summary

Background: More than two-thirds of people living with HIV live in Sub-Saharan Africa, where the HIV prevalence in the adult population (aged 15-49) is 3.9%.

In these countries a critical issue is represented by low 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 emerge 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: to assess three different interventions aimed at improving adherence and retention to Anti Retroviral therapy among HIV positive women through engagement with their life partner 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 clinical centres is limited to four, one for each intervention plus a centre 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) peer-to-peer counselling among men, "male champions"; 3) providing incentive to all women accompanied by their partners at the facility, "nudge" (note1).

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 questionnaire administered at baseline and in the post-intervention phase. Data will be collected at the clinical centres and will be stored in two electronic databases.

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 identified the better intervention to involve male partners in women's health according to an approach based on a broad spectrum of behaviours.

\- Note1: the reason of the incentive is not reward the participation in the study but is the main activity of the intervention assessed. The intervention consist in giving an incentive. For this reason is not recommendable to eliminate this information as requested by the reviewer.

Conditions

• HIV

Interventions

BEHAVIORAL

Behavioural change interventions

The study evaluates three different interventions aimed at improving adherence and retention to Anti Retroviral therapy among HIV positive women through engagement with their life partner. The interventions are 1) opening the facility once a month, only for men, "special day"; 2) testing peer-to-peer counselling among men, "male champions"; 3) providing incentive to all women accompanied by their partners at the facility, "nudge" or "incentive".

Sponsors & Collaborators

• Scuola Superiore Sant'Anna di Pisa

  collaborator OTHER

• Comunità di S.Egidio ACAP Onlus

  collaborator UNKNOWN

• Ministero degli Affari Esteri Italia

  collaborator UNKNOWN

• University of Rome Tor Vergata

  lead OTHER

Principal Investigators

• Leonardo Palombi, MD, PhD · Università Tor Vergata Roma

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2021-04-30

Completion

2023-01-30

Countries

• Malawi

Study Locations