Beyond remedicalisation: a community-led PrEP demonstration project among sex workers in India.

Global health policy-makers have called for demonstration projects to better understand pre-exposure prophylaxis' (PrEP) effectiveness across geographies and populations. Ashodaya, a sex worker collective, initiated a PrEP project in Mysore, India. We conducted a project ethnography to explore the role that community participation played within the project. Although the project proved immensely successful in terms of retention and adherence, to explain these findings we point towards Ashodaya's history of collectivisation around sexual health-a history of community action that has given rise to new spaces of belonging and accumulated knowledges that became instrumental in the formulation of strategies to confront anticipated challenges during the project. These strategies included: (1) the participation of community leaders as the first participants to take PrEP, followed by the sharing of their experiences through testimonials to their peers; (2) the endorsement of PrEP among community leaders living with HIV, to avoid social divisions around HIV status; and (3) ongoing community-level support from outreach workers that went beyond administering PrEP to address the various needs of the community. These community-led approaches demonstrate that communities hold key insights into the delivery of clinically-oriented interventions, suggesting the vital role they continue to play in planning and implementing new prevention technologies.

Potential contributions of an on-site nurse mentoring program on neonatal mortality reductions in rural Karnataka state, South India: evidence from repeat community cross-sectional surveys.

BACKGROUND: We assessed the effects of a nurse mentoring program on neonatal mortality in eight districts in India. METHODS: From 2012 to 2015, nurse mentors supported improvements in critical MNCH-related practices among health providers at primary health centres (PHCs) in northern Karnataka, South India. Baseline (n = 5240) and endline (n = 5154) surveys of randomly selected ever-married women were conducted. Neonatal mortality rates (NMR) among the last live-born children in the three years prior to each survey delivered in NM and non-NM-supported facilities were calculated and compared using survival analysis and cumulative hazard function. Mortality rates on days 1, 2-7 and 8-28 post-partum were compared. Cox survival regression analysis measured the adjusted effect on neonatal mortality of delivering in a nurse mentor supported facility. RESULTS: Overall, neonatal mortality rate in the three years preceding the baseline and endline surveys was 30.5 (95% CI 24.3-38.4) and 21.6 (95% CI 16.3-28.7) respectively. There was a substantial decline in neonatal mortality between the survey rounds among children delivered in PHCs supported by NM: 29.4 (95% CI 18.1-47.5) vs. 9.3 (95% CI 3.9-22.3) (p = 0.09). No significant declines in neonatal mortality rate were observed among children delivered in other facilities or at home. In regression analysis, among children born in nurse mentor supported facilities, the estimated hazard ratio at endline was significantly lower compared with baseline (HR: 0.23, 95% CI: 0.06-0.82, p = 0.02). CONCLUSION: The nurse mentoring program was associated with a substantial reduction in neonatal mortality. Further research is warranted to delineate whether this may be an effective strategy for reducing NMR in resource-poor settings.

'I have the confidence to ask': thickening agency among adolescent girls in Karnataka, South India.

Gender norms serve to normalise gender inequalities and constrain girls' agency. This paper examines how girls' agency, along a continuum, is influenced by the interplay between constraining and enabling influences in the girls' environments. We analyse data from a qualitative study nested within a cluster randomised evaluation of Samata, a multi-layered programme supporting adolescent girls to stay in school and delay marriage in Karnataka, South India. Specifically, we compare agency among 22 girls from intervention communities and 9 girls in control communities using data from the final round of interviews in a qualitative cohort. Using the concept of 'thin' and 'thick' agency on a continuum, we identified shocks like mothers' death or illness, poverty stress, gender norms and poor school performance as thinning influences. Good school examination results; norms in support of education; established educational aspirations; supportive parents, siblings and teachers; and strategic government and Samata resources enabled thicker agency. The intervention programme's effect increased in parallel to the gradient from thin to thicker agency among girls in progressively supportive family contexts. Engagement with the programme was however selective; families adhering to harmful gender norms were not receptive to outreach. In line with diffusion theory, late adopters required additional peer encouragement to change norms.

Changes in Family-Level Attitudes and Norms and Association with Secondary School Completion and Child Marriage Among Adolescent Girls: Results from an Exploratory Study Nested Within a Cluster-Randomised Controlled Trial in India.

We evaluated the impact of Samata, a 3-year multilayered intervention among scheduled caste/scheduled tribe (SC/ST) adolescent girls in rural northern Karnataka, on family-level (parents or guardian) attitudes and direct and indirect norms related to child marriage and girl's education. Endline data from 1840 family members were used to assess the effect of Samata on attitudes and norms related to schooling and child marriage, while data from 4097 family members (including 2257 family members at baseline) were used to understand the shifts in attitudes and norms over the period 2014-2017. Overall, we found that the programme had little impact on family-level attitudes and norms. However, there were shifts in some attitudes, norms and perceived sanctions between baseline (when girls were aged 13-14 years) and endline (when girls were aged 15-16 years), with some becoming more progressive (e.g. direct norms related to child marriage) and others more restrictive (e.g. norms around girls completing secondary education and norms related to child marriage and educational drop-out, blaming girls for eve teasing and limiting girls' mobility so as to protect family honour). Moreover, non-progressive norms related to marriage and education were strongly associated with child marriage and secondary school non-completion among adolescent girls in this rural setting. Norms hypothesised to be important for marriage and schooling outcomes were indeed associated with these outcomes, but the intervention was not able to significantly shift these norms. In part, this may have been due to the intervention focusing much of its initial efforts on working with girls alone rather than family members, the relevant reference group. Future interventions that seek to affect norms should conduct formative research to clarify the specific norms affecting the outcome(s) of interest; likewise, programme planners should ensure that all activities engage those most influential in enforcing the norm(s) from the beginning. ClinicalTrials.gov registration number: NCT01996241.

Prevalence and correlates of psychological distress among 13-14 year old adolescent girls in North Karnataka, South India: a cross-sectional study.

BACKGROUND: Mental health disorders among adolescents have emerged as a major public health issue in many low and middle-income countries, including India. There is a paucity of research on the determinants of psychological distress, particularly among the poorest girls in the poorest communities. The purpose of this study was to assess the prevalence and correlates of different indicators of psychological distress among 13-14 year old low caste girls in rural, south India. METHODS: Cross-sectional survey of 1191 low caste girls in two districts in north Karnataka, conducted as part of a cluster randomised-control trial. Bivariate and multivariate logistic regression analysis assessed correlates of different indicators of psychological distress. RESULTS: More than one third of girls (35.1%) reported having no hope for the future. 6.9% reported feeling down, depressed or hopeless in the past 2 weeks. 2.1% reported thinking they would be better off dead or of hurting themselves in some way in the past 2 weeks. 1.6% reported sexual abuse, 8.0% rrecent eve teasing and 6.3% having no parental emotional support. Suicidal ideation was independently associated with sexual abuse (AOR 11.9 (3.0-47.0)) and a lack of parental emotional support (AOR 0.2 (0.1-0.5)). Feeling down, depressed or hopeless was independently associated with recent eve-teasing (AOR 2.9 (1.6-5.4)), a harassing or abusive school environment (AOR 3.9 (1.8-8.2)), being frequently absent (AOR 2.8 (1.5-5.5)) or having dropped out of school (AOR 2.1 (1.0-4.3)), and living in Vijayapura district (AOR 2.5 (1.6-4.1)). Having no hope for the future was independently associated with a range of factors, including recent "eve-teasing" (AOR 1.5 (1.0-2.4)), being engaged (AOR 2.9 (0.9-9.7)), not participating in groups (AOR 0.5 (0.4-0.6)) and a lack of emotional support (AOR 0.6 (0.4-0.7)). CONCLUSIONS: Rather than being a time of optimism, a third of low caste girls in rural north, Karnataka have limited hope for the future, with some contemplating suicide. As well as having important development benefits, interventions that address the upstream structural and gender-norms based determinants of poor mental health, and provide adolescent services for girls who require treatment and support, should have important benefits for girls' psychological wellbeing. TRIAL REGISTRATION: Prospectively registered at ClinicalTrials.GovNCT01996241 . November 27, 2013.

Evaluation of community-based HIV self-testing delivery strategies on reducing undiagnosed HIV infection, and improving linkage to prevention and treatment services, among men who have sex with men in Kenya: a programme science study protocol.

BACKGROUND: HIV prevalence among men having sex with men (MSM) in Kenya is 18.2%. Despite scale-up of HIV testing services, many MSM remain unaware of their HIV status and thus do not benefit from accessing HIV treatment or prevention services. HIV self-testing (HIVST) may help address this gap. However, evidence is limited on how, when, and in what contexts the delivery of HIVST to MSM could increase awareness of HIV status and lead to early linkage to HIV treatment and prevention. METHODS: The study will be embedded within existing MSM-focused community-based HIV prevention and treatment programmes in 3 counties in Kenya (Kisumu, Mombasa, Kiambu). The study is designed to assess three HIV testing outcomes among MSM, namely a) coverage b) frequency of testing and c) early uptake of testing. The study will adopt a mixed methods programme science approach to the implementation and evaluation of HIVST strategies via: (i) a baseline and endline bio-behavioural survey with 1400 MSM; (ii) a socio-sexual network study with 351 MSM; (iii) a longitudinal qualitative cohort study with 72 MSM; (iv) routine programme monitoring in three sites; (v) a programme-specific costing exercise; and (vi) mathematical modelling. This protocol evaluates the impact of community-based implementation of HIV self-testing delivery strategies among MSM in Kenya on reducing the undiagnosed MSM population, and time for linkage to prevention, treatment and care following HIV self-testing. Baseline data collection started in April 2019 and the endline data collection will start in July 2020. DISCUSSION: This study is one of the first programme science studies in Sub-Saharan Africa exploring the effectiveness of integrating HIVST interventions within already existing HIV prevention and treatment programmes for MSM in Kenya at scale. Findings from this study will inform national best approaches to scale up HIVST among MSM in Kenya.

What determines violence among female sex workers in an intimate partner relationship? Findings from North Karnataka, south India.

BACKGROUND: Like other women in India, female sex workers (FSWs) frequently experience violence from their intimate partners (IPs)-a reality that increases their risk of acquiring HIV or other sexually transmitted infections. Less is known about the nature of these intimate relationships or what aspect of the relationship increases the risk of IP violence (IPV). We measured the prevalence and determinants of IPV on FSWs in the context of north Karnataka, India, characterized by high HIV-prevalence and extreme poverty. METHODS: Overall 620 FSWs with an IP participated in a baseline survey conducted for an on-going cluster-randomised controlled trial aiming to evaluate the impact of a multi-level intervention on IPV reduction. We characterize the nature of intimate relationships and explored determinants of severe physical and/or sexual IP violence using univariable and multivariable analyses. RESULTS: The median age of participants was 35 years with 10 years of duration in an intimate relationship. Though most relationships originated from a sex work encounter, 84% stated that IPs did not know they were currently practicing sex work. In past 6 months, the experience of emotional violence was 49% (95%CI:45.2-53.2), physical 33% (95%CI:29.5-37.1) and sexual violence 7% (95%CI:4.8-8.9), while 24% (95%CI:21.0-27.9) FSWs experienced recent severe physical and/or sexual violence from IPs. Factors associated with recent IPV included experience of physical and/or sexual violence from their clients in last 6 months (AOR 2.20; 95%CI: 1.29-3.75), sexual intercourse in the past 1 month when their IP was under the influence of alcohol (AOR 2.30; 95%CI: 1.47-3.59) and providing financial support to their IP (AOR 2.07; 95%CI: 1.28-3.34). CONCLUSIONS: The association between increased risk of violence and provision of financial support to an IP is indicative of gendered power dynamics as men remain dominant irrespective of their financial dependency on FSWs. Interventions are needed that address inequitable gender norms which makes FSWs tolerate violence even though she is not financially dependent on IP. Higher likelihood of violence in presence of alcohol use and FSWs' previous experience of workplace violence linked to IPV call for strengthening the crisis management systems within community-based organisations that can address all forms of violence and associated risk factors. TRIAL REGISTRATION: Clinical Trials NCT02807259.

Key Programme Science lessons from an HIV prevention 'Learning Site' for sex workers in Mombasa, Kenya.

OBJECTIVES: In 2013, Kenya's National AIDS and STI Control Programme established a Learning Site (LS) in Mombasa County to support and strengthen capacity for HIV prevention programming within organisations working with sex workers. A defining feature of LS was the use of a Programme Science approach throughout its development and implementation. We provide an overview of the key components of LS, present findings from 23 months of programme monitoring data, and highlight key Programme Science lessons from its implementation and monitoring. METHODS: Routine monitoring data collected from September 2013 through July 2015 are presented. Individual-level service utilisation data were collected monthly and indicators of interest were analysed over time to illustrate trends in enrolment, programme coverage and service utilisation among sex workers in Mombasa County. RESULTS: Over the monitoring period, outreach programme enrolment occurred rapidly; condom distribution targets were met consistently; rates of STI screening remained high and diagnoses declined; and reporting of and response to violent incidents increased. At the same time, enrolment in LS clinics was relatively low among female sex workers, and HIV testing at LS was low among both female and male sex workers. CONCLUSION: Lessons learnt from operationalising the Programme Science framework through the Mombasa LS can inform the development and implementation of similar LS in different geographical and epidemiological contexts. Importantly, meaningful involvement of sex workers in the design, implementation and monitoring processes ensures that overall programme performance is optimised in the context of local, 'on-the-ground' realities. Additionally, learnings from LS highlight the importance of introducing enhanced monitoring and evaluations systems into complex programmes to better understand and explain programme dynamics over time.

Effects of exposure to an intensive HIV-prevention programme on behavioural changes among female sex workers in Nairobi, Kenya.

While Kenya has had a long-standing national HIV-prevention programme, evidence on the level of exposure to its interventions and related effects on behavioural changes among female sex workers (FSWs) is limited. Using cross-sectional behavioural data collected in 2013 from 1 357 FSWs aged 18 years and above in Nairobi, Kenya, this study explores the relationship between FSW programme exposure levels and behavioural outcomes including condom use, sexually transmitted infection (STI)-treatment, and empowerment measures like disclosure of self-identity and violence reporting. We categorised programme exposure levels as none, moderate and intensive. Multivariate logistic regression was used for analysis. Overall, 35% of the FSWs were not exposed to any HIV prevention programme, whereas about 24% had moderate and 41% had intensive exposure. FSWs having intensive programme exposure had a higher likelihood of using condoms consistently with occasional clients (AOR: 1.57; 95% CI: 1.08-2.31) and seeking treatment for STIs (AOR: 3.37; 95% CI: 1.63-7.02) compared to FSWs with no or moderate exposure. Intensive programme exposure was also associated with higher self-disclosure of sex-work identity (AOR: 1.63; 95% CI: 1.19-2.24), reporting of violence to police (AOR: 2.45; 95% CI: 1.03-5.84), and negotiation of condom use at last sex when the client was under the influence of alcohol (AOR: 1.63; 95% CI: 0.94-2.82). Although HIV prevention programmes in Kenya have been underway for over a decade, programme efforts were largely focused on saturating the coverage (intervention breadth). Strategies should now focus on ensuring improved quality of contacts through intensified programme exposure (intervention depth) to enhance gains in behavioural change among FSWs and preventing the burden of HIV infection among them.

Improving the knowledge of labour and delivery nurses in India: a randomized controlled trial of mentoring and case sheets in primary care centres.

BACKGROUND: Birthing in health facilities in India has increased over the last few years, yet maternal and neonatal mortality rates remain high. Clinical mentoring with case sheets or checklists for nurses is viewed as essential for on-going knowledge transfer, particularly where basic training is inadequate. This paper summarizes a study of the effect of such a programme on staff knowledge and skills in a randomized trial of 295 nurses working in 108 Primary Health Centres (PHCs) in Karnataka, India. METHODS: Stratifying by district, half of the PHCs were randomly assigned to be intervention sites and provided with regular mentoring visits where case sheet/checklists were a central job and teaching aid, and half to be control sites, where no support was provided except provision of case sheets. Nurses' knowledge and skills around normal labour, labour complications and neonate issues were tested before the intervention began and again one year later. Univariate and multivariate analyses were conducted to examine the effect of mentoring and case sheets. RESULTS: Overall, on none of the 3 measures, did case sheet use without mentoring add anything to the basic nursing training when controlling for other factors. Only individuals who used both case-sheets and received mentoring scored significantly higher on the normal labour and neonate indices, scoring almost twice as high as those who only used case-sheets. This group was also associated with significantly higher scores on the complications of labour index, with their scores 2.3 times higher on average than the case sheet only control group. Individuals from facilities with 21 or more deliveries in a month tended to fare worse on all 3 indices. There were no differences in outcomes according to district or years of experience. CONCLUSIONS: This study demonstrates that provision of case sheets or checklists alone is insufficient to improve knowledge and practices. However, on-site mentoring in combination with case sheets can have a demonstrable effect on improving nurse knowledge and skills around essential obstetric and neonatal care in remote rural areas of India. We recommend scaling up of this mentoring model in order to improve staff knowledge and skills and reduce maternal and neonatal mortality in India. TRIAL REGISTRATION: This study is registered at clinicaltrials.gov, Identifier No. NCT02004912 , November 27, 2013.

Correlates of school dropout and absenteeism among adolescent girls from marginalized community in north Karnataka, south India.

Secondary education among lower caste adolescent girls living in rural Karnataka, South India, is characterized by high rates of school drop-out and absenteeism. A cross-sectional baseline survey (N=2275) was conducted in 2014 as part of a cluster-randomized control trial among adolescent girls (13-14 year) and their families from marginalized communities in two districts of north Karnataka. Bivariate and multivariate logistic regression models were used. Overall, 8.7% girls reported secondary school dropout and 8.1% reported frequent absenteeism (past month). In adjusted analyses, economic factors (household poverty; girls' work-related migration), social norms and practices (child marriage; value of girls' education), and school-related factors (poor learning environment and bullying/harassment at school) were associated with an increased odds of school dropout and absenteeism. Interventions aiming to increase secondary school retention among marginalized girls may require a multi-level approach, with synergistic components that address social, structural and economic determinants of school absenteeism and dropout.

Higher HPV16 and HPV18 Penile Viral Loads Are Associated With Decreased Human Papillomavirus Clearance in Uncircumcised Kenyan Men.

BACKGROUND: Whether higher penile human papillomavirus (HPV) viral load is associated with a lower rate of HPV clearance remains unknown. OBJECTIVES: We examined the association between penile HPV16 and HPV18 viral load and subsequent HPV clearance in uncircumcised Kenyan men. STUDY DESIGN: Participants were human immunodeficiency virus (HIV)-seronegative, sexually active, 18- to 24-year-old men randomized to the control arm of a male circumcision trial in Kisumu, Kenya. Men provided exfoliated penile cells from two anatomical sites (glans/coronal sulcus and shaft) every 6 months for 2 years. GP5+/6+ polymerase chain reaction was used to identify 44 HPV-DNA types. Human papillomavirus viral load testing was conducted using a LightCyler real-time polymerase chain reaction assay; viral load was classified as high (>250 copies/scrape) or low (≤250 copies/scrape), for nonquantifiable values. The Kaplan-Meier method and Cox regression modeling were used to examine the association between HPV viral load and HPV clearance. RESULTS: A total of 1097 men, with 291 HPV16 and 131 HPV18 cumulative infections over 24 months were analyzed. Human papillomavirus clearance at 6 months after first HPV detection was lower for high versus low viral load HPV16 infections in the glans (adjusted hazard ratio [aHR], 0.65; 95% confidence interval [CI], 0.46-0.92)] and shaft (aHR, 0.44; 95% CI, 0.16-0.90), and HPV18 infections in the glans (aHR, 0.05; 95% CI, 0.01-0.17). DISCUSSION: High versus low HPV viral load was associated with a reduced HPV clearance for HPV16 infections in the glans and shaft, and for HPV18 infections in the glans, among young uncircumcised men. Reduced clearance of high viral load HPV16 and HPV18 infections in men may increase HPV transmission to their female partners as well as enhance the development of penile lesions in comparison to men with low viral load HPV infections.

What Determines HIV Prevention Costs at Scale? Evidence from the Avahan Programme in India.

Expanding essential health services through non-government organisations (NGOs) is a central strategy for achieving universal health coverage in many low-income and middle-income countries. Human immunodeficiency virus (HIV) prevention services for key populations are commonly delivered through NGOs and have been demonstrated to be cost-effective and of substantial global public health importance. However, funding for HIV prevention remains scarce, and there are growing calls internationally to improve the efficiency of HIV prevention programmes as a key strategy to reach global HIV targets. To date, there is limited evidence on the determinants of costs of HIV prevention delivered through NGOs; and thus, policymakers have little guidance in how best to design programmes that are both effective and efficient. We collected economic costs from the Indian Avahan initiative, the largest HIV prevention project conducted globally, during the first 4 years of its implementation. We use a fixed-effect panel estimator and a random-intercept model to investigate the determinants of average cost. We find that programme design choices such as NGO scale, the extent of community involvement, the way in which support is offered to NGOs and how clinical services are organised substantially impact average cost in a grant-based payment setting.

Pornography, Sexual Enhancement Products, and Sexual Risk of Female Sex Workers and their Clients in Southern India.

Despite their large numbers, and important role in the HIV epidemic in India, male clients of female sex workers (FSWs) are a difficult to reach population and little is known about their sexual behaviors. Using data from an integrated behavioral and biological assessment of 684 clients in Bangalore in 2012, we examined factors associated with their reports of having sex with three or more different female sex workers in the last month, and anal sex with sex workers. We included sociodemographic and sexual behavior factors and, for the first time in client studies in India, included data on the use of pornography and sexual enhancement products (SEPs) such as pills, oils, and sprays, in our multivariable analyses of client risk. Seventy-eight percent of clients had seen pornographic material and 8% reported ever having used SEPs. The profiles of men practicing the two risk behaviors examined were quite different. Travel in the past year, drunkenness in the past month, young age at first commercial sex, non-use of condoms at last sex, and finding sex workers in public places (but not use of pornography and SEPs) were independently associated with multiple partnering. Sex with a man or transsexual, being a white collar worker, seeking out FSWs at home, pornography and SEP use, and condom use at last FSW sex, were all independently associated with anal sex with an FSW. More research is needed to better understand the links between pornography and SEPs, and HIV risk behaviors, and HIV prevention programs need to be cognizant of the importance of ensuring that condom use is adequately promoted and supported in the context of anal sex in female sex worker-client interactions.

Reducing violence and increasing condom use in the intimate partnerships of female sex workers: study protocol for Samvedana Plus, a cluster randomised controlled trial in Karnataka state, south India.

BACKGROUND: Female sex workers (FSWs) are at increased risk of HIV and STIs compared to women in the general population, and frequently experience violence in their working and domestic lives from a variety of perpetrators, which can enhance this risk. While progress has been made in addressing violence by police and clients, little work has been done to understand and prevent violence by intimate partners (IPs) among FSW populations. METHODS: Samvedana Plus is a multi-level intervention programme that works with FSWs, their IPs, the sex worker community, and the general population, and aims to reduce violence and increase consistent condom use within these 'intimate' relationships. The programme involves shifting norms around the acceptability of beating as a form of discipline, challenging gender roles that give men authority over women, and working with men and women to encourage new relationship models based on gender equity and respect. The programme will aim to cover 800 FSWs and their IPs living in 47 villages in Bagalkot district, northern Karnataka. The study is designed to assess two primary outcomes: the proportion of FSWs who report: (i) physical or sexual partner violence; and (ii) consistent condom use in their intimate relationship, within the past 6 months. The evaluation will employ a cluster-randomised controlled trial design, with 50 % of the village clusters (n = 24) randomly selected to receive the intervention for the first 24 months and the remaining 50 % (n = 23) receiving the intervention thereafter. Statisticians will be blinded to treatment arm allocation. The evaluation will use an adjusted, cluster-level intention to treat analysis, comparing outcomes in intervention and control villages at midline (12 months) and endline (24 months). The evaluation design will involve quantitative and qualitative assessments with (i) all FSWs who report an IP (ii) IPs; and process/ implementation monitoring. Baseline data collection was completed in April 2015, and endline data collection is anticipated in May 2017. CONCLUSIONS: This is an innovative intervention programme that aims to address violence by IPs as part of HIV prevention programming with FSWs. Reducing violence is expected to reduce vulnerability to HIV acquisition, and help women to work and live without fear of violence. TRIAL REGISTRATION: Clinical Trials NCT02807259 Jun 24 2016 (retrospectively registered).

Acquisition and persistence of human papillomavirus 16 (HPV-16) and HPV-18 among men with high-HPV viral load infections in a circumcision trial in Kisumu, Kenya.

BACKGROUND: Circumcision and lower human papillomavirus (HPV) viral loads in men are possibly associated with a reduced risk of HPV transmission to women. However, the association between male circumcision and HPV viral load remains unclear. METHODS: Swab specimens from the glans and shaft of the penis were collected from men enrolled in a circumcision trial in Kisumu, Kenya. GP5+/6+ polymerase chain reaction (PCR) was used to identify HPV DNA types. HPV-16 and HPV-18 loads were measured with a LightCycler real-time PCR and classified as high (>250 copies/scrape) or low (≤250 copies/scrape). RESULTS: A total of 1159 men were randomly assigned to undergo immediate circumcision, and 1140 men were randomly assigned to the control arm (these individuals were asked to remain uncircumcised until the study ended). The hazard of acquisition of high-viral load infections in the glans was lower in the circumcision arm, compared with the control arm, for HPV-16 (hazard ratio [HR], 0.32 [95% confidence interval {CI}, .20-.49]) and HPV-18 (HR, 0.34 [95% CI, .21-.54]). The 6-month risk of HPV persistence among men with high-viral load infections in the glans at baseline was lower in the circumcision arm, compared with the control arm, for HPV-16 (risk ratio [RR], 0.36 [95% CI, .18-.72]) and HPV-18 (RR 0.34 [95% CI, .13-.86]). Weaker and less precise results were obtained for shaft samples. CONCLUSIONS: Male circumcision could potentially reduce the risk of HPV transmission to women by reducing the hazard of acquisition, and the risk of persistence of high-HPV viral load infections in the glans in men.

Fertility intentions, power relations and condom use within intimate and other non-paying partnerships of women in sex work in Bagalkot District, South India.

This study aimed to: (1) examine the relationship between interpersonal as well as social-demographic, cultural and structural factors, and condom non-use by sex workers' main intimate or other non-paying male sex partners (NPPs), as reported by a sample of sex workers (SWs); and (2) understand HIV/sexually transmitted infections (STIs) risk (e.g., numbers of sexual partners; condom use with different partners) among couples comprised of a sub-set of SWs and their NPPs. Bivariate and multivariable logistic regression was used to identify factors associated with condom non-use at last sex by the main NPP, as reported by SWs. Adjusted odds ratios and 95% confidence intervals are reported (AOR[95%CIs]). Data were drawn from cross-sectional surveys in Bagalkot District, Karnataka State, South India. Responses by SWs whose main NPPs agreed to enrol in the study and the main NPP enroled were linked; these responses by couples (pairs of SWs and NPPs) were examined to assess sexual risk for HIV/STIs. Overall, this study included 257 SWs and 76 NPPs. The data from 67 couples (88.2%) could be linked. In over a quarter of partnerships, at least one (SW or NPP) partner reported having another type of partner besides each other (and clients of SWs). In multivariable analysis, significantly increased odds of condom non-use at last sex with the main NPP were found for the following key factors: planning to have a child with their main NPP (AOR = 3.71[1.44-9.58]); and having decisions about condom use made by their main NPP (AOR = 9.87[4.03-24.16]) or both equally (AOR = 3.18[1.39-7.80]) (versus by the SWs herself). Our study highlights the potential risk for HIV/STI acquisition and transmission between NPPs and SWs, and between NPPs and their non-SWs wives and other sex partners. Study results underscore the need for HIV/STI prevention approaches that incorporate informed decision-making about childbearing and parenting, and empowerment strategies for SWs in the context of their relationships with NPPs.

Preferences for infant delivery site among pregnant women and new mothers in Northern Karnataka, India.

BACKGROUND: The National Rural Health Mission (NRHM) of India aims to increase the uptake of safe and institutional delivery among rural communities to improve maternal, neonatal and child health (MNCH) outcomes. Previous studies in India have found that while there have been increasing numbers of institutional deliveries there are still considerable barriers to utilization and quality of services, particularly in rural areas, that may mitigate improvements achieved by MNCH interventions. This paper aims to explore the factors influencing preference for home, public or private hospital delivery among rural pregnant and new mothers in three northern districts of Karnataka state, South India. METHODS: In-depth qualitative interviews were conducted in 2010 among 110 pregnant women, new mothers (infants born within past 3 months), their husbands and mothers-in-law. Interviews were conducted in the local language (Kannada) and then translated to English for analysis. The interviews of pregnant women and new mothers were used for analysis to ultimately develop broader themes around definitions of quality care from the perspective of service users, and the influence this had on their delivery site preferences. RESULTS: Geographical and financial access were important barriers to accessing institutional delivery services in all districts, and among those both above and below the poverty line. Access issues of greatest concern were high costs at private institutions, continuing fees at public hospitals and the inconsistent receipt of government incentives. However, views on quality of care that shaped delivery site preferences were deeply rooted in socio-cultural expectations for comfortable, respectful and safe care that must ultimately be addressed to change negative perceptions about institutional, and particularly public hospital, care at delivery. CONCLUSIONS: In the literature, quality of care beyond access has largely been overlooked in favour of support for incentives on the demand side, and more trained doctors, facilities and equipment on the supply side. Taking a comprehensive approach to quality of care in line with cultural values and community needs is imperative for improving experiences, utilization, and ultimately maternal and neonatal health outcomes at the time of delivery.

Pregnancy wastage among HIV infected women in a high HIV prevalence district of India.

BACKGROUND: Bagalkot district in Karnataka state is one of the highest HIV prevalence districts in India. A large proportion of the girls also marry at early age in the district and negative pregnancy outcomes among the HIV positive women likely to have large pregnancy wastages. Therefore, this study examined the pregnancy wastages and the associated factors among HIV positive women in a high prevalent district in India. METHODS: We used data from a cross-sectional survey conducted recently among randomly selected currently married HIV positive women, 15-29 years of age, in one of the high HIV prevalence districts in India. The study used the experience of reported pregnancy wastage as an outcome variable, and both bi-variate and multivariate logistic regression analyses were carried out to understand the factors associated with the pregnancy wastage among HIV infected women. RESULTS: Overall, 17% of the respondents reported pregnancy wastage, of which 81% were due to spontaneous abortions. Respondents who became pregnant since testing HIV positive reported significantly higher level of pregnancy wastage as compared to those were pregnant before they were tested for HIV. (AOR = 1.9; p = 0.00). While a positive association between duration of marriage and pregnancy wastage was noticed (AOR = 7.4; p = 0.01), there was a negative association between number of living children and pregnancy wastage (AOR = 0.24; p = 0.00). Living in a joint family was associated with increased reporting of pregnancy wastage as compared to those living in nuclear families (AOR = 1.7; p = 0.03). CONCLUSIONS: HIV prevention and care programs need to consider the reproductive health needs of HIV infected married women as a priority area since large proportion of these women reported negative pregnancy outcomes. There is also a need to explore ways to raise the age at marriage in order to stop women getting married before the legal age at marriage.

Supporting adolescent girls to stay in school, reduce child marriage and reduce entry into sex work as HIV risk prevention in north Karnataka, India: protocol for a cluster randomised controlled trial.

BACKGROUND: Low caste adolescent girls living in rural northern Karnataka are at increased risk of school drop-out, child marriage, and entry into sex-work, which enhances their vulnerability to HIV, early pregnancy and adverse maternal and child health outcomes. This protocol describes the evaluation of Samata, a comprehensive, multi-level intervention designed to address these structural drivers of HIV risk and vulnerability. METHODS/DESIGN: The Samata study is a cluster randomised controlled trial that will be conducted in eighty village clusters (40 intervention; 40 control) in Bijapur and Bagalkot districts in northern Karnataka. The intervention seeks to reach low caste girls and their families; adolescent boys; village communities; high school teachers and school governing committees; and local government officials. All low caste (scheduled caste/tribe) adolescent girls attending 7th standard (final year of primary school) will be recruited into the study in two consecutive waves, one year apart. Girls (n = 2100), their families (n = 2100) and school teachers (n = 650) will be interviewed at baseline and at endline. The study is designed to assess the impact of the intervention on four primary outcomes: the proportion of low caste girls who (i) enter into secondary school; (ii) complete secondary school; (iii) marry before age 15; and (iv) engage in sex before age 15. Observers assessing the outcomes will be blinded to group assignment. The primary outcome will be an adjusted, cluster-level intention to treat analysis, comparing outcomes in intervention and control villages at follow-up. We will also conduct survival analyses for the following secondary outcomes: marriage, sexual debut, pregnancy and entry into sex work. Complementary monitoring and evaluation, qualitative and economic research will be used to explore and describe intervention implementation, the pathways through which change occurs, and the cost-effectiveness of the intervention. DISCUSSION: This is an innovative trial of a comprehensive intervention to improve the quality of life and reduce HIV vulnerability among marginalised girls in northern Karnataka. The findings will be of interest to programme implementers, policy makers and evaluation researchers working in the development, education, and sexual and reproductive health fields. TRIAL REGISTRATION: ClinicalTrials.Gov NCT01996241 . 16th November 2013.