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

NCT04356157 | Unknown

• 1 other identifier: AID-011587/08/05
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Retention; Adherence; Male involvement; HIV; Interventions; Malawi

Outcome Measures

Primary Outcomes (1)

• Retention in care and adherence to treatment

  Retention in care will be measured as the cumulative proportion of dropouts from the treatment program at 6 months, 1 year, and 2 years (excluding patients transferred to another centre or those who died). Adherence will be measured through the following indicators: (1) The cumulative proportion of medical appointments missed in a month period in the centre; (2) the cumulative proportion of appointments for drug delivery missed in a month period in the centre; (3) the cumulative proportion of women who suppressed viral load; (4) the cumulative proportion of women with a suppressed viral load that have a re-bound in viremia.

  2 years

Secondary Outcomes (4)

• Male Involvement - Proportion of women accompanied by partners

  2 years

• Male Involvement 2 - Proportion of men accepting HIV testing and counselling

  2 years

• Male Involvement 3 - Score scale of MI in health practices reported from female partners

  2 years

• Male Involvement 4 - Score scale of Gender Based Violence reported from female partner

  2 years

Study Arms (4)

Special day

OTHER

The special day takes place with an extraordinary opening of the clinical centre once a month on a pre-festive day (Saturday). During this day, access will be reserved exclusively for men, including those who are not on treatment for HIV. The centre will offer free health promotion services to all participants.

Behavioral: Behavioural change interventions

Male Champions

OTHER

The "male champion" is a figure present in a few settings which carries out home visits with men and couples and follows up with men who did not accompany their partners to Antenatal Care visits. Usually, this role is covered by the female Expert Clients, namely HIV+ patients working in the organization as volunteers after appropriate training. Some men among patients who are on treatment will be identified and trained to cover this role.

Behavioral: Behavioural change interventions

Nudge

OTHER

The intervention based on the use of incentives (nudge) to men who follow the prevention and treatment program aims to evaluate whether this action is effective in guiding behaviour change towards the test, treatment, involvement and adherence to therapy approach.

Behavioral: Behavioural change interventions

No intervention

OTHER

No intervention will be carried out in a center.

Behavioral: Behavioural change interventions

Interventions

Behavioural change interventions BEHAVIORAL

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".

Male Champions; No intervention; Nudge; Special day

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being HIV positive
• Age of 18 years or older
• Living at home with a male partner

You may not qualify if:

• No HIV positive
• No included in a HIV/AIDS prevention and treatment program
• Under 18 years old
• No partner living at home

Sponsors & Collaborators

• University of Rome Tor Vergata: lead
• Scuola Superiore Sant'Anna di Pisa: collaborator
• Comunità di S.Egidio ACAP Onlus: collaborator
• Ministero degli Affari Esteri Italia: collaborator

Study Sites (4)

Balaka DREAM centre

Balaka, Malawi

RECRUITING

Kapeni DREAM centre

Blantyre, Malawi

RECRUITING

Namandanje DREAM centre

Machinga, Malawi

RECRUITING

Kapire DREAM centre

Mangochi, Malawi

RECRUITING

Related Publications (6)

• Triulzi I, Palla I, Ciccacci F, Orlando S, Palombi L, Turchetti G. The effectiveness of interventions to involve men living with HIV positive pregnant women in low-income countries: a systematic review of the literature. BMC Health Serv Res. 2019 Dec 9;19(1):943. doi: 10.1186/s12913-019-4689-6.

  PMID: 31815620 BACKGROUND

• Aliyu MH, Sam-Agudu NA, Shenoi S, Goga AE, Ramraj T, Vermund SH, Audet CM. Increasing male engagement in the prevention of vertical transmission of HIV: what works in sub-Saharan Africa? BMJ. 2019 Jun 6;365:l1965. doi: 10.1136/bmj.l1965.

  PMID: 31171558 BACKGROUND

• Takah NF, Kennedy ITR, Johnman C. The impact of approaches in improving male partner involvement in the prevention of mother-to-child transmission of HIV on the uptake of maternal antiretroviral therapy among HIV-seropositive pregnant women in sub-Saharan Africa: a systematic review and meta-analysis. BMJ Open. 2017 Nov 25;7(11):e018207. doi: 10.1136/bmjopen-2017-018207.

  PMID: 29175889 BACKGROUND

• Mancinelli S, Nielsen-Saines K, Germano P, Guidotti G, Buonomo E, Scarcella P, Lunghi R, Sangare H, Orlando S, Liotta G, Marazzi MC, Palombi L. Who will be lost? Identifying patients at risk of loss to follow-up in Malawi. The DREAM Program Experience. HIV Med. 2017 Sep;18(8):573-579. doi: 10.1111/hiv.12492. Epub 2017 Feb 2.

  PMID: 28150466 BACKGROUND

• Matseke MG, Ruiter RAC, Rodriguez VJ, Peltzer K, Setswe G, Sifunda S. Factors Associated with Male Partner Involvement in Programs for the Prevention of Mother-to-Child Transmission of HIV in Rural South Africa. Int J Environ Res Public Health. 2017 Nov 1;14(11):1333. doi: 10.3390/ijerph14111333.

  PMID: 29104275 BACKGROUND

• Kaufman MR, Cornish F, Zimmerman RS, Johnson BT. Health behavior change models for HIV prevention and AIDS care: practical recommendations for a multi-level approach. J Acquir Immune Defic Syndr. 2014 Aug 15;66 Suppl 3(Suppl 3):S250-8. doi: 10.1097/QAI.0000000000000236.

  PMID: 25007194 BACKGROUND

Related Links

• DREAM programme website

Study Officials

• Leonardo Palombi, MD, PhD

  Università Tor Vergata Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Orlando, PhD

CONTACT

+393285699419; stefano.orlando@uniroma2.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: The three interventions to be implemented and evaluated in the research plan are designed to assess the involvement of MI at individual level, interpersonal/network, community-level, Health System and structural level according to ecological model. The study is articulated in three phases: pre-intervention, intervention and post-intervention analyses. In the pre-intervention analysis, the baseline situation of the three participating centres will be evaluated. The aim of this phase is to set a starting point in order to weigh the relative effect of each intervention to be studied. In each clinical centre baseline data will be collected. In order to evaluate the effect of the interventions, the same indicators will be measured in pre-and in post-intervention phase. The enrollment of participants will be consecutively based on the order of patient appointments.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 22, 2020
• Study Start: July 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: January 30, 2023
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

MA (4)