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A gender synchronized family planning intervention for married couples in rural India: study protocol for the CHARM2 cluster randomized controlled trial evaluation.

ABSTRACT: BACKGROUND:Prior research from India demonstrates a need for family planning counseling that engages both women and men, offers complete family planning method mix, and focuses on gender equity and reduces marital sexual violence (MSV) to promote modern contraceptive use. Effectiveness of the three-session (two male-only sessions and one couple session) Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention, which used male health providers to engage and counsel husbands on gender equity and family planning (GE?+?FP), was demonstrated by increased pill and condom use and a reduction in MSV. However, the intervention had limited reach to women and was therefore unable to expand access to highly effective long acting reversible contraceptives such as the intrauterine device (IUD). We developed a second iteration of the intervention, CHARM2, which retains the three sessions from the original CHARM but adds female provider- delivered counseling to women and offers a broader array of contraceptives including IUDs. This protocol describes the evaluation of CHARM2 in rural Maharashtra. METHODS:A two-arm cluster randomized controlled trial will evaluate CHARM2, a gender synchronized GE?+?FP intervention. Eligible married couples (n =?1200) will be enrolled across 20 clusters in rural Maharashtra, India. Health providers will be gender-matched to deliver two GE?+?FP sessions to the married couples in parallel, and then a final session will be delivered to the couple together. We will conduct surveys on demographics as well as GE and FP indicators at baseline, 9-month, and 18-month follow-ups with both men and women, and pregnancy tests at each time point from women. In-depth interviews will be conducted with a subsample of couples (n =?50) and providers (n =?20). We will conduct several implementation and monitoring activities for purposes of assuring fidelity to intervention design and quality of implementation, including recruitment and tracking logs, provider evaluation forms, session observation forms, and participant satisfaction surveys. DISCUSSION:We will complete the recruitment of participants and collection of baseline data by July 2019. Findings from this work will offer important insight for the expansion of the national family planning program and improving quality of care for India and family planning interventions globally. TRIAL REGISTRATION:ClinicalTrial.gov, NCT03514914 .

SUBMITTER: Dixit A

PROVIDER: S-EPMC6593563 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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A gender synchronized family planning intervention for married couples in rural India: study protocol for the CHARM2 cluster randomized controlled trial evaluation.

Dixit Anvita A Averbach Sarah S Yore Jennifer J Kully Gennifer G Ghule Mohan M Battala Madhusudana M Begum Shahina S Johns Nicole E NE Vaida Florin F Bharadwaj Prashant P Wyss Natalie N Saggurti Niranjan N Silverman Jay J Raj Anita A

Reproductive health 20190625 1

<h4>Background</h4>Prior research from India demonstrates a need for family planning counseling that engages both women and men, offers complete family planning method mix, and focuses on gender equity and reduces marital sexual violence (MSV) to promote modern contraceptive use. Effectiveness of the three-session (two male-only sessions and one couple session) Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention, which used male health providers to engage a ...[more]

PMID: 31238954

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Project description:BackgroundDespite calls for gender transformative family planning interventions to increase male engagement and female reproductive agency, there is limited research involving rigorous evaluation of the integration of these approaches. CHARM2 (counseling Husbands and wives to Achieve Reproductive Health and Marital Equity) builds upon a prior three-session male engagement intervention by integrating female-focused sessions emphasizing women's choice and agency (i.e., gender synchronization). We hypothesized that CHARM2 participants will be more likely to report marital contraceptive use and communication and women's contraceptive agency, and less likely to report unintended pregnancy, relative to participants in the control condition.MethodsWe conducted a two-armed cluster randomized controlled trial evaluating the effects of CHARM2 on marital contraceptive use, communication, decision-making; women's contraceptive agency, and pregnancy among young married couples in rural Maharashtra, India (ClinicalTrials.gov #NCT03514914, complete). 40 geographic clusters, defined based on the catchment areas of subcenter health facilities (the most proximal level of community health care within India's public health system) were randomized to control (n = 20) and intervention (n = 20). We assigned all participants within that geographic cluster to the corresponding cluster treatment condition; participants, investigators, and study staff were not masked to treatment assignment. Eligibility criteria included wife aged 18-29, couple residing together for at least six months with no plan for migration, and neither spouse sterilized or infertile. The CHARM2 intervention included five provider-delivered sessions on gender equity and family planning, two delivered in parallel to husbands and wives separately by gender-matched providers, and one final joint session, delivered within the four months subsequent to baseline survey. We conducted surveys and pregnancy testing at baseline and 9-month and 18-month follow-up. We used difference-in-differences multilevel mixed effects logistic regressions to assess CHARM2 effects on marital contraceptive use and communication, and women's contraceptive agency; we used single time point mixed effects logistic regressions for pregnancy outcomes. All analyses used an intention-to-treat approach.Findings1201 couples were recruited between September 2018 and June 2019; 600 intervention and 601 control. All couples were included in outcome analyses. Full couple retention was 90·2% (n = 1083) at 9-month follow-up and 90·5% (n = 1087) at 18-month follow-up. Modern contraceptive use was higher among intervention participants at 9-month but not 18-month follow-up (9-month adjusted ratio of odds ratio [AROR] 1·5, 95% CI 1·03-2·3; 18-month AROR 0·8, 95% CI 0·4-1·4). Communication (9-month AROR 1·9, 95% CI 1·0-3·6; 18-month AROR 2·7, 95% CI 1·5-4·8) and agency (9-month AROR 5·1, 95% CI 1·2-22·4; 18-month AROR 8·1, 95% CI 1·4-48·2) both improved at both time points. There was no significant difference in pregnancy between groups over the 18-month period (AOR 0·8, 95% CI 0·7-1.1) However, for women who expressed fertility ambivalence at baseline, unintended pregnancy was marginally less likely among intervention participants (47% vs 19%) (p = 0·07). There were no reported adverse events.InterpretationThe CHARM2 intervention offers a scalable model to improve contraceptive use, communication, and agency and possibly decrease unplanned pregnancies for couples in rural India.

Project description:BackgroundDespite ongoing recommendations to increase male engagement and gender-equity (GE) counseling in family planning (FP) services, few such programs have been implemented and rigorously evaluated. This study evaluates the impact of CHARM, a three-session GE+FP counseling intervention delivered by male health care providers to married men, alone (sessions 1&2) and with their wives (session 3) in India.Methods and findingsA two-armed cluster randomized controlled trial was conducted with young married couples (N = 1081 couples) recruited from 50 geographic clusters (25 clusters randomized to CHARM and a control condition, respectively) in rural Maharashtra, India. Couples were surveyed on demographics, contraceptive behaviors, and intimate partner violence (IPV) attitudes and behaviors at baseline and 9 &18-month follow-ups, with pregnancy testing at baseline and 18-month follow-up. Outcome effects on contraceptive use and incident pregnancy, and secondarily, on contraceptive communication and men's IPV attitudes and behaviors, were assessed using logistic generalized linear mixed models. Most men recruited from CHARM communities (91.3%) received at least one CHARM intervention session; 52.5% received the couple's session with their wife. Findings document that women from the CHARM condition, relative to controls, were more likely to report contraceptive communication at 9-month follow-up (AOR = 1.77, p = 0.04) and modern contraceptive use at 9 and 18-month follow-ups (AORs = 1.57-1.58, p = 0.05), and they were less likely to report sexual IPV at 18-month follow-up (AOR = 0.48, p = 0.01). Men in the CHARM condition were less likely than those in the control clusters to report attitudes accepting of sexual IPV at 9-month (AOR = 0.64, p = 0.03) and 18-month (AOR = 0.51, p = 0.004) follow-up, and attitudes accepting of physical IPV at 18-month follow-up (AOR = 0.64, p = 0.02). No significant effect on pregnancy was seen.ConclusionsFindings demonstrate that men can be engaged in FP programming in rural India, and that such an approach inclusive of GE counseling can improve contraceptive practices and reduce sexual IPV in married couples.Trial registrationClinicalTrials.gov NCT01593943.

Project description:Background: There is increasing programming and research on male engagement and gender-equity (GE) counselling in family planning (FP) services. However, there is a lack of data on healthcare provider's perspectives on delivering these interventions. The objective of the paper is to present providers' perspectives on delivering a GE-focused FP intervention, CHARM, to married couples in rural India. Methods: In-depth interviews were carried out with 22 male village health care providers who were delivering a GE-focused FP intervention, CHARM, to 428 husbands (247 couples) rural Maharashtra, India. Providers were interviewed on their experiences and perspectives during delivery of CHARM. Major domains were identified during a thematic analysis. Results: Local male health providers are interested and can be engaged in delivering a GE-focused FP intervention. Providers believed that the CHARM intervention improves couples' communication, contraceptive use and strengthened their own capacity to provide FP services in accordance with national FP programmatic efforts. Providers found the low-tech flipchart including pictures and information helpful in supporting their service provision. Providers reported some challenges including lack of privacy and space for counselling, limited access to contraceptive options beyond pill and condom, numerous myths and misconceptions about contraceptives. Providers also reported persistent social norms related to expectancy of pregnancy early in marriage, and son preference. Conclusions: Providers in rural areas with high fertility and related maternal health complications are interested in and can successfully implement a GE-focused FP intervention. Future efforts using this approach may benefit from greater focus to support broader array of spacing contraceptives particularly among first time parents, none or one child parents. There is a need to better support engagement of wives possibly through female provider led sessions parallel to male programs, i.e. gender synchronized rather than couples' sessions. Trial registration: ClinicalTrials.gov NCT01593943, May 8, 2012.

Project description:BACKGROUND:Globally, 41% of all pregnancies are unintended, increasing risk for unsafe abortion, miscarriage and maternal and child morbidities and mortality. One in four pregnancies in India (3.3 million pregnancies, annually) are unintended; 2/3 of these occur in the context of no modern contraceptive use. In addition, no contraceptive use until desired number and sex composition of children is achieved remains a norm in India. Research shows that globally and in India, the youngest and most newly married wives are least likely to use contraception and most likely to report husband's exclusive family planning decision-making control, suggesting that male engagement and family planning support is important for this group. Thus, the Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention was developed in recognition of the need for more male engagement family planning models that include gender equity counseling and focus on spacing contraception use in rural India. METHODS/DESIGN:For this study, a multi-session intervention delivered to men but inclusive of their wives was developed and evaluated as a two-armed cluster randomized controlled design study conducted across 50 mapped clusters in rural Maharashtra, India. Eligible rural young husbands and their wives (N?=?1081) participated in a three session gender-equity focused family planning program delivered to the men (Sessions 1 and 2) and their wives (Session 3) by village health providers in rural India. Survey assessments were conducted at baseline and 9&18 month follow-ups with eligible men and their wives, and pregnancy tests were obtained from wives at baseline and 18-month follow-up. Additional in-depth understanding of how intervention impact occurred was assessed via in-depth interviews at 18 month follow-up with VHPs and a subsample of couples (n?=?50, 2 couples per intervention cluster). Process evaluation was conducted to collect feedback from husbands, wives, and VHPs on program quality and to ascertain whether program elements were implemented according to curriculum protocols. Fidelity to intervention protocol was assessed via review of clinical records. DISCUSSION:All study procedures were completed in February 2015. Findings from this work offer important contributions to the growing field of male engagement in family planning, globally. TRIAL REGISTRATION:ClinicalTrial.gov, NCT01593943.

Project description:BackgroundEarly marriage and early childbearing are highly prevalent in Niger with 75% of girls married before age 18 years and 42% of girls giving birth between ages 15 and 18 years. In 2012, only 7% of all 15-19-year-old married adolescents (male and female) reported use of a modern contraceptive method with barriers including misinformation, and social norms unsupportive of contraception. To meet the needs of married adolescents and their husbands in Niger, the Reaching Married Adolescents (RMA) program was developed with the goal of improving modern contraceptive method uptake in the Dosso region of Niger.MethodsUsing a four-arm cluster randomized control design, the RMA study seeks to assess whether household visits only (Arm 1), small group discussions only (Arm 2), or a combination of both (Arm 3), as compared to controls (no intervention - Arm 4), improve modern contraceptive method use among married adolescent girls and young women (AGYW), age 13-19 years-old, in three districts of the Dosso region. Intervention conditions were randomly assigned across the three districts, Dosso, Doutchi, and Loga. Within each district, eligible villages were assigned to either that intervention condition or to the control condition (12 intervention and 4 control per district). Across the three intervention conditions, community dialogues regarding modern contraceptive use were also implemented. Data for the study was collected at baseline (April - June 2016), at 24 months post-intervention (April - June 2018), and a final round of data collection will occur at 40 months post-intervention (October - December 2019).DiscussionThe RMA intervention is a gender-synchronized and community-based program implemented among married adolescent girls and their husbands in the context of rural Niger. The intervention is designed to provide education about modern contraception and to promote gender equity in order to increase uptake of modern contraceptive methods. Results from this cluster randomized control study will contribute to the knowledge base regarding the utility of male engagement as a strategy within community-level approaches to promote modern contraceptive method use in the high need context of West Africa.Trial registrationRegistered October 2017 - ClinicalTrials.gov NCT03226730.

Project description:BackgroundUganda has one of the highest fertility rates globally, but only 30% of women report using an effective method of contraception. Community-based, multi-level interventions are needed to help couples in rural Uganda overcome barriers to contraceptive use.MethodsThis study will pilot test the Family Health = Family Wealth intervention, a multi-level, community-based intervention employing transformative community dialogues, which use facilitated discussion to reshape community norms that influence family planning acceptance, to alter individual attitudes and the perception of community norms that discourage family planning. Community dialogues are delivered to groups of couples over 4 sessions (two gender-segregated and two gender-mixed). Sessions simultaneously address individual and interpersonal-level determinants of family planning and link couples to family planning services. At the health system level, a refresher training will be conducted with health workers in the intervention community's health center to address gaps in contraceptive knowledge and skills as identified from a needs assessment. The intervention will be evaluated through a pilot quasi-experimental trial paired with a mixed methods process evaluation. Participants include 70 couples (N=140) randomized by community to the Family Health = Family Wealth intervention (n=35 couples) or to an attention-matched water, sanitation, and hygiene (WASH) intervention (n=35 couples). Participants include sexually active, married couples who are age 18 (or an emancipated minor) to 40 for women and age 18 (or an emancipated minor) to 50 for men, not pregnant, at least one person in the couple reports wanting to avoid pregnancy for at least a year, and not currently using a method of contraception or using a low-efficacy or ineffective method of contraception. The primary aims of the study are to (1) assess the feasibility of the intervention trial procedures, (2) the acceptability and feasibility of the intervention content and structure, and (3) explore the intervention's preliminary effectiveness at increasing contraceptive use and affecting related outcomes among couples.DiscussionFilling the unmet need for family planning has important public health implications, including reductions in pregnancy-related health risks and deaths, and infant mortality. This pilot intervention trial will gather preliminary evidence on the acceptability, feasibility, and potential effect of a novel, multi-level, community-based intervention to increase contraceptive use among couples with an unmet need for family planning in rural Uganda. We aim to use the findings of this pilot study to refine the trial procedures and intervention content for a future, larger cluster randomized controlled trial to establish the intervention's efficacy.Trial registrationClinicalTrials.gov NCT04262882; registered on February 10, 2020.

Project description:Introduction/objectivesMale involvement in family planning refers to all organizational actions focused on men as a distinct group to increase the acceptability and uptake of family planning among either sex. Despite the growing evidence of male involvement in increasing family planning uptake among couples, a little success has been achieved in Ethiopia, especially in rural areas. Hence, this study aimed to assess male involvement in family planning and its associated factors among currently married men in selected rural areas of Eastern Ethiopia.MethodsA community-based cross-sectional survey was conducted among 577 randomly selected currently married men, using a simple random sampling method in randomly selected rural districts of Eastern Ethiopia. Data were collected using a pretested interviewer-administered questionnaire. The collected data were entered into a computer using Epi-Data Version 3.1. The analysis was performed using the Statistical Package for the social sciences software version 21. Logistic regression analysis was used to analyze the association between the dependent and independent variables. Finally, adjusted odds ratio with 95% confidence intervals at P-value < 0.05 was considered to be significantly associated with the outcome variable.ResultsOut of 577, a total of, 555 married men were included in the study, resulting in a response rate of 96.2%. The magnitude of male involvement in family planning use was 59.3% (95% confidence interval: 47.1, 68. 2). Ever use of family planning by a spouse (adjusted odds ratio: 2.37; 95% confidence interval: 1.59, 3.52), ever discussion of spouse on sexual and reproductive health/family planning issues (adjusted odds ratio: 2.05; 95% confidence interval: 1.40, 3.02), and the husband's approval of family planning (adjusted odds ratio: 2.45; 95% confidence interval: 1.34, 4.96) were significantly associated with higher odds of male involvement in family planning use than their counterparts.ConclusionThe number of men involved in the family planning was low. Ever use of family planning methods by a spouse, ever discussion of spouse on sexual and reproductive health/family planning issues, and husband approval on family planning use were found to be important predictors of male involvement in family planning use. To improve modern family planning uptake among men and women, it is imperative to include men in family planning programs, such as family planning messaging, sensitizations, and services.

Dataset Information

A gender synchronized family planning intervention for married couples in rural India: study protocol for the CHARM2 cluster randomized controlled trial evaluation.

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A gender synchronized family planning intervention for married couples in rural India: study protocol for the CHARM2 cluster randomized controlled trial evaluation.

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