Despite the availability of a dual therapy treatment protocol (Nevirapine + AZT) and infant feeding guidelines designed to prevent mother to child transmission (PMTCT) of HIV, of the over 1 million babies born in South Africa each year, only 70% of those born to HIV positive mothers receive dual therapy . Similar to other resource-poor nations facing the integration of PMTCT into routine pregnancy and infant care, efforts in South Africa to scale up PMTCT and reduce transmission to < 5% have fallen far short of the UN goal of 50% reductions in paediatric HIV by 80% coverage of mothers . Bringing transmission rates below 5% represents potentially saving 75,000 babies of the 300,000 exposed to HIV annually. Mpumulanga Province, the focus of the current application, has consistently had one of the lowest rates of PMTCT; 69% of pregnant women received PMTCT services in 2009. Despite increases in uptake in other regions  Mpumalanga has the highest HIV prevalence (4.5%) among children (0-18 years) in South Africa . PMTCT program failure occurs at all stages of the process in South Africa . Implementation of PMTCT programs in already overburdened clinical settings presents multiple challenges, including systemic (e.g., failure to offer ARV prophylaxis, home delivery), social (e.g., stigma, lack of disclosure), individual (e.g., maternal failure to ingest medication or provide it to the infant, failure to obtain antenatal testing) and interpersonal (e.g., lack of male involvement, intimate partner violence) factors. Increasing male participation as a method to enhance implementation of PMTCT and increase uptake of and commitment to the medical protocol for pregnancy and newborn care has been identified as a potentially critical strategy for PEPFAR countries [6, 7]. This application proposes an implementation strategy to test whether male involvement will increase PMTCT uptake utilizing the existing public health program linking antenatal HIV Counselling and Testing (HCT) and PMTCT services.
Male involvement is also essential due to a related issue, the disturbingly high rate of HIV seroconversion (3%) during pregnancy in South Africa . This suggests the continuation of unprotected high risk sex during the middle to latter stages of pregnancy may go undetected for the purposes of PMTCT unless women are re-tested just prior to delivery . Again, male involvement in the antenatal/HCT process may also influence and reduce risk of HIV exposure during this critical period. Prevention of Mother to Child Transmission (PMTCT) has played the major role in reducing child mortality associated with HIV/AIDS and improving maternal health [10, 11]. Guidelines for the use of antiretroviral therapies to reduce transmission have been implemented in the most HIV affected countries, especially those in sub-Saharan Africa . The PMTCT program in South Africa consists of comprehensive counselling, HIV-testing and the offer of ARV prophylaxis for seropositive mothers and their newborns and referral of HIV positive mothers and their families for CD4 count assessment for antiretroviral therapy . However, despite the widespread availability of PMTCT, not all mothers provided with medication take it themselves or provide it to their newborns [13–17] due to a variety of circumstances, including unwillingness or perceived inability to disclose their HIV status to their partners . Mother to child transmission rates range from 12% to > 20% in South Africa and drop out is high at all stages of the PMTCT process .
To date, HCT for pregnant women has largely been organized on an individual and sex-specific basis in PMTCT programs, typically ignored by male partners. However, a couples approach to HCT and antenatal care facilitates communication about HIV serostatus, thereby reducing one of the major barriers to acceptance of ARV prophylaxis by mothers for themselves and their newborns, as well as encouraging adoption of preventive behaviours within couples to reduce HIV incidence during pregnancy  The need for male involvement in the PMTCT process has been increasingly encouraged to improve adherence to ARV prophylaxis [20, 21] though no randomized clinical trials of the influence of male partners as key contributors to acceptance and PMTCT uptake have been conducted. HCT and prevention strategies for couples in stable relationships could also strengthen HIV prevention efforts  in Southern Africa, where the majority of HIV infections occur in stable relationships. Prevention programs to increase male involvement in Tanzania, Botswana and Zambia have met with some success, e.g., Tanzania found male involvement increased NVP uptake , Botswana utilized a media campaign and increased male involvement from 4% to 11%, and Zambia utilized monetary incentives and couples counselling and increased male involvement in PMTCT . In Cote d'Ivoire, prenatal couple counselling and testing improved couples' communication on sexual risks among both HIV positive and negative women . In Kenya, partner participation in HCT and couples counselling increased Nevirapine and formula feeding uptake among women attending antenatal clinics  and partner attendance to 15% [27, 28]. In Rwanda and Zambia, couples HCT led to enhanced follow up among pregnant women at both sites but did not increase Nevirapine uptake . However, while PMTCT attendance by both members of a couple is feasible , uptake remains limited by lack of male participation  highlighting the need to increase communication within the couple about reproduction and sexual health 
Men's attitudes regarding involvement in PMTCT and antenatal care (ANC) programs have been linked to cultural barriers, including the perception that male participation in ANC/PMTCT services is superfluous and that ANC is "a woman's responsibility" [30, 10]. Additionally, men in Tanzania were found to have general HIV knowledge but to lack specific information regarding PMTCT and unable to attend PMTCT programs due to timings which conflict with their work schedules. Similarly, in Zambia, men were perceived as decision makers in the home and felt their position was undermined if they were expected to attend a "women's clinic program", leading them to decline to attend ANC and PMTCT with their partners , with as few as 2% attending urban ANC (personal communication, Provincial Health Office, Lusaka, Zambia). In Botswana, men regarded ANC health facilities as being "generally unfriendly" to them. Most recently, a review of studies incorporating men suggested that male "support" as well as "involvement" is key to increasing PMTCT uptake 
As noted, 3% of women in South Africa seroconvert during pregnancy following receipt of HIV negative test results [9, 8]. Following diagnosis, partners may not disclose their serostatus  or protect an uninfected partner  These data highlight the urgent need to incorporate strategies in conjunction with the PMTCT process to prevent HIV transmission to mothers during pregnancy [34, 35]. This team's previous research in the US and Zambia has found that a gender specific group, sexual behaviour intervention designed to increase couples communication, the Partner Project, enhanced the acceptability and use of sexual barrier products (male and female condoms) among HIV seropositive men  and women [37, 38]. We also increased need for multiple session interventions among those in serodiscordant relationships, who appear to represent a unique population within those couples living with HIV . The Partner Project, currently being implemented in community health clinics across Zambia by CDC Zambia, has achieved 95-100% retention of enrolled couples over 6 months and 90-95% over 12 months and maintained comparative levels of participation by both men and women throughout the intervention.
Aim of the study
The aim of the study is to evaluate the impact of combining two evidence-based interventions: a couple's risk reduction intervention with an evidence based medication adherence intervention to enhance male participation in combination with improving medication and PMTCT adherence in antenatal clinics (ANCs) to increase PMTCT overall reach and effectiveness. The study will use a group-randomized design, recruiting 240 couples from 12 clinics. Clinics will be randomly assigned to experimental and control conditions and effectiveness of the combined intervention to enhance PMTCT as well as reduce antenatal seroconversion by both individuals and clinics will be examined.
Study objectives are to enhance PMTCT effectiveness by 1) increasing male partner participation in the PMTCT process, 2) increasing male HCT, 3) increasing maternal and infant adherence to the overall PMTCT protocol and 4) increasing the use of sexual barriers and reducing HIV transmission to mothers during pregnancy.