Investigating the quality and validity of a promising intervention

India has the third highest population of people living with HIV. Despite HIV infection and prevalence rates in India being among the lowest in the world, the country’s large population translates into a higher total number of HIV-infected individuals than in countries with smaller populations.

In 2011, the Joint United Nations Programme on HIV/AIDS (UNAIDS) named India as one of 22 focal countries for its “Global Plan Towards the Elimination of New HIV Infections among Children by 2015 and Keeping Their Mothers Alive.” At that time, an estimated 2.9 million people in India were infected and living with HIV, and between 2009 and 2011 the number of children infected each year remained high.

Since the mid-1990s Anti-Retroviral drugs have played a large role in reducing the number of infected children born to mothers with HIV, but in resource-poor areas such as the state of Maharashtra, mothers are less likely to access such treatment, increasing the likelihood of transmission.

Complementing Medication and Treatment with Patient Outreach

World Health Organization guidelines for prevention of mother-to-child HIV transmission encompass four key actions for providers and mothers:

• Provide universal ARV therapy to HIV-positive pregnant and breastfeeding women, regardless of their CD4 count.( CD4 cells are a type of white blood cell that play a major role in protecting the body from infection, the higher the count, the better one is able to fight HIV and other infections.)
• Provide daily prophylaxis to HIV-exposed infants
• Promote exclusive breast feeding for 6 months
• Engage and retain women in pre- and postpartum HIV care to facilitate early diagnosis of their infants.

The Indian government’s Department of AIDS Control accepted those guidelines and added to them a national outreach component they dubbed Option B+, which aims to increase follow-up before and after delivery to ensure that infants receive proper care for their first 18 months.

Funded by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), Option B+ trained peer-aged mothers, both HIV positive and not, to serve as outreach workers. These women encourage HIV-positive mothers to continue care after delivery and report on their health status to district coordinators. Option B+ is currently operational in 247 districts throughout India at newly established centers called Integrated Counseling and Testing Centers (ICTCs).

Auditing a Study of Effective Strategies to Prevent Mother-to-Child Transmission

Under a joint effort, PEPFAR and CDC’s Division of Global HIV/AIDS are supporting a study of the effectiveness of Option B+—known as the Community Home-Based India Prevention of Mother-to-Child Transmission of HIV (COMBIND PMTCT) Study. COMBIND PMTCT aims to guide strategies for improving national policies in support of preventing mother-to-child HIV transmission (PMTCT) in India.

COMBIND PMTCT compares Option B+ to another enhanced and integrated approach to improve the capacity of outreach workers visiting patients in their homes. The study is being performed in four districts of Maharashtra to understand the efficacy of the interventions and improved access to treatment.

Our 18-month audit requires special expertise, in part, because of the infrastructure limitations in Maharashtra and local researchers’ limited experience in conducting formal study designs. Our research specialists are evaluating the ethical and regulatory compliance of 117 treatment sites, as well as the integrity of the data that contributes to the overall scientific validity of the study.

The study has both qualitative and quantitative components, including focus groups and in-depth interviews to assess the impact and acceptability of the program for patients and outreach workers, and to assess the feasibility of using a mobile, open-source comprehensive health application to collect data.

Identifying Effective Approaches to Decreasing Mother-to-Child Transmission of HIV

Our audit is important in building the research capacities of local HIV treatment experts, whose work under the COMBIND PMTCT study will shed light on the effectiveness of these novel approaches in reducing the transmission of HIV from mothers to their babies. These data will enable resource-constrained ministries, NGOs, and health care providers across India to focus on programs that are proven to work.

The value of these findings can also be extended to other areas of the world where mother-to-child transmission rates continue to be high.