Please select the eligibility criteria that correspond to the clinical trial below.
Title: Gender Equity-Focused, Male-Centered Family Planning for Rural India
Brief Summary: The major barrier to India meeting its national goal of replacement fertility is the huge discrepancy between urban and rural family planning, with rural young women at highest risk for unplanned and unspaced pregnancies. These concerns are considered to drive the persistent and unacceptably high rates of maternal and infant mortality in India. Major impediments to these young wives' acquisition of family planning services include high male partner control over reproductive decision-making, low mobility, and very low access to family planning services in villages. Such findings document the need for male-centered family planning efforts available at the village level, to better meet the needs of rural young wives. These male-centered efforts must address male gender role and gender inequity ideologies and norms (e.g., son preference, wife abuse) and marital communication, as these factors are associated with lower likelihood of contraceptive use in rural young Indian couples. Hence, the proposed study involves development and testing of the CHARM Program, a gender equity (GE)-focused, male-centered family planning (FP) program delivered by village health providers (VHPs), via a public-private partnership with primary health centers (PHCs) and private providers serving rural India. In Phase 1 the investigators will conduct formative research including health care resource mapping of Vasai within the Thane district of Maharashtra to identify villages and VHPs for inclusion in subsequent research and intervention. The investigators will also conduct in-depth interviews with rural young husbands (n=30), rural young wives (n=20), and health care providers (n=12), as well as focus groups with mothers' of rural young husbands (n=40). These data will be used to develop the CHARM program and efficacy trial. Phase 2 will involve development and pilot testing of CHARM protocols and training of VHPs for their role in the intervention trial (Phase 3). The CHARM intervention will involve VHP-delivered GE and FP counseling. It is delivered via a single session with 2 optional additional sessions one of which would include their wife. Phase 3 will involve evaluation of CHARM, using a two-armed randomized controlled trial design. Villages (N=50) will be randomized to receive either CHARM or the control program (standard FP referral to government public health centers \[PHCs\] located outside of villages), to assess treatment impact on spacing contraceptive use, pregnancy, and unmet family planning need. Intervention effects will be assessed via behavioral surveys with rural young husbands (18-30 years) and their wives (N=1000 couples, 20 couples per village) at baseline and 9 and 18 month follow-up, as well as pregnancy tests from wives, conducted at baseline and 18 month follow-up. A process evaluation will be undertaken via interviews with study participants and VHPs, as well as through VHP interviews and clinical record review, to assess program adherence, participation rates, response to program, and ease of delivery. In-depth interviews will also be conducted with key informants from the village and public and rural health systems to assess sustainability and institutionalization of the model.


Options:
A: Inclusion Criteria:

1. Aged 15-29 years
2. Presenting for elective termination of an unintended pregnancy
3. Has not had contraceptive counseling from the team.
4. Willing and able to understand and comply with study protocol
5. Willing and able to sign an informed consent in English

Exclusion Criteria:

1. Current pregnancy intended
2. Current pregnancy desired
3. Reason for pregnancy termination not elective (e.g. fetal anomalies, pregnancy resulted from rape or incest)
4. Plans pregnancy within 6 months
5. Has been administered any sedatives or cervical ripening agents
6. For minors, must not be a ward of the state.
B: Inclusion Criteria:

* Mexican American,
* 14 - 45 years old,
* English Speaking,
* non-viral sexually transmitted infection

Exclusion Criteria:

* Non-English speaking,
* viral sexually transmitted infection
C: Primary study participants for intervention evaluation are rural young men (n=1500) and their wives (n=1500). Inclusion and exclusion criteria for these men are as follows:

INCLUSION CRITERIA

* Age 18-30 years and Fluent in Marathi
* Willing to Have Wife Included in the Study
* Residing in the village for the past 2 years and residing with wife in village for past 3 months

EXCLUSION CRITERIA

* Sterile or Wife is Sterile
* Cognitive Impairment (husband or wife)
* Intend to move in next 18 months
D: Inclusion Criteria:

* At least 18 years old
* HIV-positive patients receiving care at a project clinic and seen at the clinic at least twice prior to enrollment
* Sexually active within the past three months
* Planning to attend the clinic for at least 1 year
* Able to conduct interview in one of the following languages:

Kenya: English, Kiswahili Namibia: English, Oshiwambo, Damara-nama, Otjiherero, Afrikaans Tanzania: English, Kiswahili

* Able to provide informed consent to participate in the project

Exclusion Criteria:

* Younger than 18 years of age
* Not sexually active within the last three months
* Planning to move from the vicinity of the clinic within one year
* Not enrolled in the HIV clinic and/or have not been seen for at least two clinic visits
* Cannot provide informed consent
* Patients who are acutely ill or are determined by clinical staff to be too ill to participate
* Spouses or identified partners of participating patients
* Pregnant women and male partners of pregnant women, as family planning counseling and unintended pregnancy are some of the primary study outcomes
* Not able to complete interview in one of the languages in the inclusion criteria
* Participated in pilot study

Answer: C