Ethical Challenges of Randomized Violence Intervention Trials: Examining the SHARE intervention in Rakai, Uganda.

ObjectiveWe identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda.MethodsConcepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs.ResultsExisting ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial.ConclusionStudies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits

Addressing Intimate Partner Violence Among Female Clients Accessing HIV Testing and Counseling Services: Pilot Testing Tools in Rakai, Uganda.

The World Health Organization recommends that HIV counseling and testing (HCT) programs implement strategies to address how intimate partner violence (IPV) influences women's ability to protect themselves from and seek care and treatment for HIV infection. We discuss the process used to adapt a screening and brief intervention (SBI) for female clients of HCT services in Rakai, Uganda-a setting with high prevalence of both HIV and IPV. By outlining our collaborative process for adapting and implementing the SBI in Rakai and training counselors for its use, we hope other HCT programs will consider replicating the approach in their settings

Intimate partner violence, HIV and sexually transmitted infections in fishing, trading and agrarian communities in Rakai, Uganda.

BackgroundIntimate partner violence (IPV), HIV and sexually transmitted infections (STI) can contribute to disparities in population health, depending on the individual, social and environmental factors characterizing a setting. To better understand the place-based determinants and patterns of these key interrelated public health problems in Uganda, we compared risk factors for IPV, HIV and STI in fishing, trading and agrarian communities in Rakai, Uganda by gender.MethodThis study used cross-sectional data collected from 14,464 sexually active men (n = 6531) and women (n = 7933) as part of the Rakai Community Cohort Study, a population-based open cohort study of men and women aged 15-49 years. We used multilevel modified poisson regression models, which incorporated random intercepts for community and households. Factors associated with IPV, HIV and STI were assessed separately for men and women in fishing, trading and agrarian communities.ResultsA larger proportion of participants in the fishing communities than those in trading and agrarian communities were HIV positive, engaged in HIV risk behaviors, had STI symptoms and reported perpetration of or victimization by IPV. Female gender was a shared correlate of IPV, HIV and STI in the fishing communities. Engagement in multiple sexual relationships or partner's engagement in multiple relationships were shared correlates of IPV, and HIV in agrarian communities and IPV and STI in trading communities.ConclusionPrograms should target factors at multiple levels to reduce risk for syndemic conditions of HIV, STI and IPV in Rakai, Uganda particularly among men and women in fishing communities

Perceptions of Adolescent Pregnancy Among Teenage Girls in Rakai, Uganda.

The leading causes of death and disability among Ugandan female adolescents aged 15 to 19 years are pregnancy complications, unsafe abortions, and childbirth. Despite these statistics, our understanding of how girls perceive adolescent pregnancy is limited. This qualitative study explored the social and contextual factors shaping the perceptions of adolescent pregnancy and childbirth among a sample of 12 currently pregnant and 14 never pregnant girls living in the rural Rakai District of Uganda. Interviews were conducted to elicit perceived risk factors for pregnancy, associated community attitudes, and personal opinions on adolescent pregnancy. Findings indicate that notions of adolescent pregnancy are primarily influenced by perceptions of control over getting pregnant and readiness for childbearing. Premarital pregnancy was perceived as negative whereas postmarital pregnancy was regarded as positive. Greater understanding of the individual and contextual factors influencing perceptions can aid in development of salient, culturally appropriate policies and programs to mitigate unintended adolescent pregnancies

Comparison of mHealth and face-to-face interventions for smoking cessation among people living with HIV : meta-analysis

Background: The prevalence of smoking among people living with HIV (PLHIV) is higher than in the general population and a significant risk factor for non-communicable diseases in this group. Mobile phone interventions to promote healthier behaviours (mHealth) have the potential to reach a large number of people at a low cost. It has been hypothesized that mHealth interventions may not be as effective as face-to-face strategies in achieving smoking cessation, but there is no systematic evidence to support this, especially among PLHIV. Objective: To compare two modes of intervention delivery (mobile technology versus face-to-face) for smoking cessation among PLHIV. Methods: Literature on randomised controlled trials (RCTs) investigating the effects of mHealth or face-to-face intervention strategies on short-term (4 weeks to <6 months) and long-term (≥6 months) smoking abstinence among PLHIV were sought. We systematically reviewed the relevant RCTs and conducted pairwise meta-analyses to estimate the relative treatment effects of mHealth and face-to-face interventions using standard care as comparison. Given the absence of head-to-head trials comparing mHealth with face-to-face interventions, we performed an adjusted indirect comparison meta-analyses to compare these interventions. Results: Ten studies involving 1,772 PLHIV met the inclusion criteria. Average age of the study population was 45 years and women comprised about 37%. At short term, mHealth delivered interventions were significantly more efficacious in increasing smoking cessation than no intervention control (Risk Ratios [RR] 2.81, 95% CI 1.44 to 5.49) and face-to-face interventions (RR 2.31, 95% CI 1.13 to 4.72). At short-term, face-to-face interventions were no more effective than no intervention in increasing smoking cessation (RR 1.22, 95% CI 0.94 to 1.58). In terms of achieving long term results among PLHIV, there was no significant difference in the rates of smoking cessation between mHealth delivered, face-to-face interventions and those who received no intervention. Conclusions: Compared with face-to-face interventions, mHealth delivered interventions can better increase smoking cessation rate in the short term. However, it remains unclear how long the effects of such interventions last. Future research should focus on strategies for sustaining the treatment effect in the long term

HIV infection in rural households, Rakai district, Uganda

The Rakai Project conducted a population-based cohort study in rural Rakai District, Uganda, a region with high rates of HIV prevalence. The cohort population described here was followed between 1990 and 1992 and consisted of all residents aged 15 years or more living in 1945 households in 31 community clusters. A detailed census was conducted at baseline in every study household. Census data were updated annually, and all inter-survey deaths, births, and migrations were recorded. Immediately following each annual census, all consenting adults were administered a socio-demographic, behavioural and health survey, and provided a blood sample for HIV testing. HIV prevalence in the study population was high, with 19.1 per cent of adults aged 15 or more years being HIV-positive. By household, the burden of infection was even more pronounced: 31.3 per cent of households had at least one HIV-infected resident adult. Twenty seven per cent of heads of households were also HIV-positive. Overall, 3.6 per cent of study households experienced the death of an HIV-positive adult per year, and another two per cent lost an HIV-negative adult. HIV-related adult mortality had substantially more effect on subsequent household dependency ratio and on material possessions than the death of an HIV-uninfected adult, in part because the former deaths were concentrated in adults aged 15-49, the most economically active age group in this rural population. Just under 15 per cent of children aged 14 years or less had lost one or both parents, and approximately half of these parental losses are estimated to be associated with HIV infection. Nineteen per cent of study households reported at least one resident child who had lost one or both parents. Although there is evidence that loss of a parent is associated with lower school attendance, orphans overall continue to be absorbed by community households which are headed by adults. HIV infection is very prevalent among adults in Rakai and the associated mortality imposes a substantial social and economic burden on households in the district

"The Bottle Is My Wife": Exploring Reasons Why Men Drink Alcohol in Ugandan Fishing Communities.

Fishing communities in Uganda have high rates of excessive alcohol consumption and negative health outcomes related to alcohol consumption, such as HIV acquisition and transmission and intimate partner violence victimization and perpetration. Research lacks understanding of alcohol use in Ugandan fishing communities, underlying reasons for excessive drinking among fishermen or how their community perceives negative health outcomes linked to excessive alcohol consumption. This qualitative study was conducted among Ugandan fisherfolk to determine why excessive alcohol consumption has overtaken their communities. Through analyzing in-depth interviews and focus group discussions, reasons for drinking and community perceptions of drinking were explored using the Socio Ecological Model and the Time Perspective Theory. Interviews were coded into two content themes: social influences on drinking and using alcohol to cope with stress. Participants acknowledged links between excessive alcohol consumption and negative health outcomes within their families and communities. These findings highlight the need for alcohol-related reduction interventions that are sensitive to contextual factors and self-identified contributors to problematic alcohol use within individuals and their communities. Such interventions must consider the social, ecological and economic conditions within fishing sites, focusing not only on individual-level behavioral change but also challenging the underlying structures that foster excessive alcohol consumption

The impact of intimate partner violence on women's contraceptive use: Evidence from the Rakai Community Cohort Study in Rakai, Uganda.

A systematic review of longitudinal studies suggests that intimate partner violence (IPV) is associated with reduced contraceptive use, but most included studies were limited to two time points. We used seven waves of data from the Rakai Community Cohort Study in Rakai, Uganda to estimate the effect of prior year IPV at one visit on women's current contraceptive use at the following visit. We used inverse probability of treatment-weighted marginal structural models (MSMs) to estimate the relative risk of current contraceptive use comparing women who were exposed to emotional, physical, and/or sexual IPV during the year prior to interview to those who were not. We accounted for time-fixed and time-varying confounders and prior IPV and adjusted standard errors for repeated measures within individuals. The analysis included 7923 women interviewed between 2001 and 2013. In the weighted MSMs, women who experienced any form of prior year IPV were 20% less likely to use condoms at last sex than women who had not (95% CI: 0.12, 0.26). We did not find evidence that IPV affects current use of modern contraception (RR: 0.99; 95% CI: 0.95, 1.03); however, current use of a partner-dependent method was 27% lower among women who reported any form of prior-year IPV compared to women who had not (95% CI: 0.20, 0.33). Women who experienced prior-year IPV were less likely to use condoms and other forms of contraception that required negotiation with their male partners and more likely to use contraception that they could hide from their male partners. Longitudinal studies in Rakai and elsewhere have found that women who experience IPV have a higher rate of HIV than women who do not. Our finding that women who experience IPV are less likely to use condoms may help explain the relation between IPV and HIV

Associations between HIV Antiretroviral Therapy and the Prevalence and Incidence of Pregnancy in Rakai, Uganda

Background. Use of antiretroviral therapy (ART) may be associated with higher pregnancy rates. Methods. The prevalence and incidence of pregnancy was assessed in 712 HIV+ pre-ART women of reproductive age (WRA) (15–45) and 244 HIV+ WRA initiating ART. Prevalence rate ratios (PRR), incidence rate ratios (IRR), and 95% confidence interval (CI) were assessed. Results. The incidence of pregnancy was 13.1/100 py among women in pre-ART care compared to 24.6/100 py among women on ART (IRR = 0.54; 95% CI 0.37, 0.81, p < 0.0017). The prevalence of pregnancy at ART initiation was 12.0% with CD4 counts 100–250 compared with 3.2% with CD4 <100 (PRR = 3.24, CI 1.51–6.93), and the incidence of pregnancy while on ART was highest in women with a good immunologic response. Desire for more children was a very important factor in fertility. Conclusion. ART was associated with increased pregnancy rates in HIV+ women, particularly those with higher CD4 counts and good immunologic response to therapy, suggesting a need to strengthen reproductive health services for both women and their partners that could address their fertility decisions/intentions particularly after ART initiation

Process evaluation of the SHARE intervention for preventing intimate partner violence and HIV infection in Rakai, Uganda.

The Safe Homes And Respect for Everyone (SHARE) intervention introduced an intimate partner violence (IPV) prevention approach into Rakai Health Sciences Program, an established HIV research and service organization in Uganda. A trial found exposure to SHARE was associated with reductions in IPV and HIV incidence. This mixed methods process evaluation was conducted between August 2007 and December 2009, with people living in SHARE intervention clusters, to assess awareness about/participation in SHARE, motivators and barriers to involvement, and perceptions of how SHARE contributed to behavior change. Surveys were conducted with 1407 Rakai Community Cohort Study participants. Qualitative interviews were conducted with 20 key informants. Most (77%) were aware of SHARE, among whom 73% participated in intervention activities. Two-thirds of those who participated in SHARE felt it influenced behavior change related to IPV. While some felt confident to take part in new IPV-focused activities of a well-established program, others were suspicious of SHARE's motivations, implying awareness raising is critical. Many activities appealed to the majority (e.g., community drama) while interest in some activities was limited to men (e.g., film shows), suggesting multiple intervention components is ideal for wide-reaching programming. The SHARE model offers a promising, acceptable approach for integrating IPV prevention into HIV and other established health programs in sub-Saharan Africa