BACKGROUND. 

In India, as in elsewhere, routine antenatal care (ANC) involves screening pregnant women for diseases that are stigmatizing. Examples of stigmatizing diseases include HIV or SCD. As a pregnant woman discloses her positive test result to her husband, she becomes vulnerable to experiencing physical and/or emotional abuse in the hand of her husband. This phenomenon known as intimate partner violence (IPV). IPV against women is to be avoided at all times and especially so during pregnancy. This is because maternal experience of IPV during pregnancy can result in these women experiencing adverse pregnancy and childbirth outcomes including pregnancy loss, preterm delivery or delivering low birth weight babies.

CURRENT STUDY. 

We will conduct the study in Nagpur, India, where ANC clinics diagnose pregnant women for SCD in two steps. First, ANC clinics screen women for the presence of sickle cells using the solubility test. The solubility test yields a "positive" or "negative" result. Positive test results mean that women have either SCD or sickle cell trait (SCT). Partner disclosure of a positive test result is a risk factor for IPV. The objective of this study is to inform adaptation of a couple-based HIV screening and disclosure intervention, called Jamii Bora, for SCT/SCD, with an explicit focus on IPV prevention and mental-health promotion.

RESEARCH METHODS. 

Study population: Pregnant couples (pregnant women with a positive solubility test result and their male partners), antenatal care providers who would deliver the intervention (i.e., auxiliary nurse-midwives), and other stakeholders (Accredited Social Health Activists [ASHA] workers (a cadre of community-based lay health workers), medical officers; Nagpur Municipal Corporation [NMC] health officer. 

Data collection methods: via a one-time in-depth interviews (IDI) of pregnant women seeking care in one of two primary health centers (Indira Gandhi Rugnalaya and Panchpaoli) in Nagpur, India, their male partners, auxiliary nurse midwives, medical officers, and the Nagpur Medical Corporation health officer. We will interview pregnant couples in which the female partner had a positive solubility test result. Sample size and sampling. We will collect data from up to 43 participants including 12 (6/PHC) pregnant women with a positive test, their male partners (12), 12 nurse-midwives, 6 (3/PHC) medical officers, and 1 NMC officer, sampled purposively based on association with study PHCs, a positive test, no IPV in the last six months, and agreeing her male partner can be contacted. To recruit “information-rich cases,” our sampling strategy will be purposive based on association with study PHCs, a positive test, no IPV in the last six months, and agreeing her male partner can be contacted. Sample recruitment and consenting procedure. Using a

recruitment script, a study coordinator will approach pregnant women attending study clinics to ask them about their interest in learning more about the study. The interested women will be asked to conduct a brief agreement form prior to be introduced to the study. Those who agree will be screened for eligibility using the eligibility form. Male partners of the eligible women (who will have consented that the study coordinator can approach her male partner) will be screened for eligibility using the eligibility form. Both pregnant women and their male partners will go through consenting process separately. Women go through the consent process including providing consent that the study team may approach their male partners, prior to their male partners going through the consent process. Data collection procedures. All IDIs will be conducted in Marathi (the local language) at a private location at study clinics by female and male qualitative researchers. We will provide additional training on research ethics and procedures. IDIs will last for 45-60 minutes and will be audio-recorded with digital recorders. Pregnant women and their male partners will be compensated in kind (nutritious food baskets) or in cash, as per recommendation of the local IRB. IDIs with pregnant women with a positive test result and their male partners will focus on structural, individual, and relationship factors shaping their reactions to women’s positive test results. IDIs with nurse-midwives, medical officers, and the health officer will also be conducted at a private location at study clinics by qualitative researchers. These IDIs, too, will last for 45-60 minutes and will be audio-recorded with digital recorder. The IDIs with nurse-midwives, medical officers, and the health officer will contribute to the understanding of provider-level barriers and facilitators of intervention implementation (e.g., provider knowledge of patient needs and resources) and organizational values, resources, and priorities, and provider role overload, access to knowledge and information, self-efficacy and rewards and incentives. Also, IDIs will solicit provider opinions on the feasibility of postponing partner disclosure of a positive test until SCT/SCD confirmation. 

Data analysis: All IDI audio files will be uploaded to an encrypted, password protected server at the local partner’s Nagpur office. IDI outputs will be transcribed verbatim in Marathi and translated into English by qualitative interviewers, and securely transferred to BU via Secure Mail. A Boston- based research assistant and I will conduct independent data analysis. .

This study will inform the preliminary adaptation of the Jamii Bora intervention (an evidence-based HIV-status disclosure intervention) for the disclosure of sickle cell disease (SCD) screening test results in Nagpur, India. The finalization of the adaptation of the intervention will be done via feedback from (A) a 10 member from a Community Advisory Board (who will provide feedback on the intervention adaptation in terms of contextual and cultural appropriateness, and (B) a 3-member panel of experts who will provide feedback on the manual on intervention implementation. These two types of feedback will result in the facilitator manual development for use for nurse training on intervention implementation. CAB and expert consultation and nurse training do not involve research engaging human subjects, and so have not been discussed in this application.