PI: KAITLIN GECK
Affiliation: VANDERBILT UNIVERSITY SCHOOL OF MEDICINE & INSTITUTE OF GLOBAL HEALTHV
Approving ERC: AMREF
Approval Date: 11/30/2017
Duration: January- March, 2018
Lwala Community Alliance serves to build the capacity of people of North Kamagambo in Migori County, Kenya to advance their own comprehensive well-being. Part of this initiative includes providing contraceptives and education about family planning.
PI: Peter Gichangi
Affiliation: Internation Centre for Reproductive Health
Approving ERC: AMREF
Approval Date: 19/06/2017
Duration: 2 months
Adolescent pregnancies are more likely in poor, uneducated and rural communities. In some countries, becoming pregnant outside marriage is not uncommon. By contrast, some girls may face social pressure to marry and, once married, to have children. More than 30% of girls in low- and middle-income countries marry before they are 18; around 14% before they are 15. (WHO, 2014). In Kenya, teenage pregnancy is not only a reproductive health issue, but is also a multi facet issue as it directly affects the current and future socio-economic well-being of women.
PI: Paul Mbaga
Affiliation: University of Kwazulu Natal
Approving ERC: AMREF
Approval Date: 21/07/2017
Duration: 6 months
Progress in accessing adolescent sexual & reproductive health (ASRH) and HIV care for persons with disabilities (PWD) in Sub-Saharan Africa has remained slow. In Kenya, like in the rest of the region, poor public financing for health; inadequate staffing; lack of equipment and commodities; inefficiencies including poor governance and management; are real maladies of the health system despite the growing ASRH& HIV care needs for PWD who face constant risk of HIV/STI; unplanned pregnancies; unsafe abortions; sexual and gender based violence.
Several studies have reported on individuals that remain persistently seronegative despite repeated exposure to the HIV type 1 (HIV-1). These have included health care workers with accidental exposure (1), infants born to infected mothers (2-4), needle-sharing intravenous drug users (5), individuals engaged in unprotected sexual intercourse (6,7) and prostitutes (8,9). The risk for infection among these cohorts varied greatly, and T cell-mediated immunity, as measured by interleukin (IL)-2 production, lymphocyte proliferation in response to HIV-derived peptides or HIV-specific cytotoxic T lymphocytes, was thought to contribute to resistance in these cases (1-4,6,7,9,10). The proposed mechanism involved priming of T cell responses with low antigenic doses, and generation of cytokine-mediated T helper cell type 1 (Th1) immune responses, which upregulate cellular effector functions and downregulate T cell help for B cells .
Although HIV incidence in sub-Saharan Africa has been in slow decline, the epidemic continues in the region, with an estimated 1.8 million people newly infected in 2009 alone (Joint United Nations Program on HIV/AIDS [UNAIDS], 2010). Importantly, young women are disproportionately affected (Gouws, Staneckib, Lyerla, & Ghys, 2008; UNAIDS, 2010). In Kenya, women ages 20–24 are four times more likely to be HIV positive (7.4%) than men of the same age group (1.9%) (National AIDS and STI Control Programme [NASCOP], 2009). Researchers and policymakers have paid increasing attention to the role of transactional sex, or the exchange of money and gifts (what we refer to as “transfers”) within non-marital relationships, as a key explanation for the gender difference in infection rates (Côté et al., 2004; Dunkle, Jewkes, Brown, Gray, McIntryre, & Harlow, 2004; Hope, 2007).
HIV spread continues at high rates from infected persons to their sexual partners. In 2009, an estimated 2.6 million new infections occurred globally. People living with HIV (PLHIV) receiving treatment are in contact with health workers and therefore exposed to prevention messages. By contrast, PLHIV not receiving ART often fall outside the ambit of prevention programs. There is little information on their sexual risk behaviors. This study in Mombasa Kenya therefore explored sexual behaviors of PLHIV not receiving any HIV treatment.
We determined the prevalence of four sexually transmitted infections and the demographic and behavioural correlates associated with having one or more sexually transmitted infections among participants in an HIV incidence cohort study in Kisumu, western Kenya.
We determined the prevalence of four sexually transmitted infections and the demographic and behavioural correlates associated with having one or more sexually transmitted infections among participants in an HIV incidence cohort study in Kisumu, western Kenya.
To more effectively control HIV epidemics, correlates of HIV infection need to be better understood, and prevention strategies adapted to account for risk patterns linked to particular settings or situations. Several factors have been associated with HIV infection in sub-Saharan Africa, including extramarital sex, multiple sexual partners,inconsistent or lack of condom use, the absence of male circumcision,and most recently, hormonal contraceptive use. Physiological factors, such as having a sexually transmitted infection (STI), particularly ulcerative genital diseases such as herpes simplex virus type 2 (HSV-2), have also been found to increase infectiousness and susceptibility to HIV infection via a variety of biological mechanisms.
Adolescents have the highest HIV incidence of any age group and are the only age group in which HIV-related mortality increased between 2005 and 2013. While substantial progress has been made in HIV testing and treatment for adult populations, there has been less programmatic focus on adolescents (aged 10–19 years) and young adults (aged 20–24 years). Eighty-three per cent of all adolescents living with HIV reside in sub-Saharan Africa (SSA), and yet just 9–13% of adolescent boys and girls in the region have tested for HIV in the past year.
Sub-Saharan Africa bears the burden of the highest rates of HIV in the world, accounting for approximately 70% of new HIV infections worldwide . Of these, approximately 30% occur among young people aged 15–24 years. In Sub-Saharan Africa, men are considered important drivers of the HIV epidemic, as heterosexual sex is the primary mode of HIV transmission, and patriarchal norms, present in many societies, increase men's power in sexual decision-making. For young males, such cultural norms can place reputational value on sexual activity, contributing to early sexual debut. The cultural and behavioral patterns that impact male youths' sexual risk are perpetuated in many ways, including parental influence. Parents may teach and shape beliefs and behaviors that promote sons' risky behavior. Fathers likely play an especially important role, as they are uniquely positioned to pass down masculine gender norms. Despite the relevance of examining fathers' influence on sons' sexual risk, little is known about this association, in part because fathers are generally under-represented in research on adolescent development . Understanding how fathers' and sons' sexual beliefs and behaviors are related and how parenting might influence that relationship has the potential to inform strategies for decreasing adolescents' HIV risk.
The 2014 WHO guidelines on adolescents and HIV recommend HIV testing and counseling (HTC) with linkage to prevention, treatment, and care for all adolescents in the settings of generalized epidemics. As the global community intensifies case finding among adolescents and youth, it becomes evident that there is an unmet need for efficient linkage to care and treatment among these populations. Most HTC and linkage to care and treatment services for adolescents and youth tend to replicate strategies designed for adults and frequently do not take into account the specific barriers faced by adolescents and youth, such as economic, legal, and social dependence; inadequate provider skills in caring for and communicating with adolescents and youth; and requirements for involvement of a guardian. There has been a paucity of data regarding targeted interventions to improve linkage to care among adolescents living with HIV in Sub-Saharan Africa.
We conducted a prospective cohort study of HIV-positive men ages 18-35 years in Kisumu, Kenya to determine if medical circumcision of ART-naive HIV-positive men leads to increased viral load and penile viral shedding.
Research on the intimate partnerships of female sex workers (FSWs) tends to focus on the risks associated with these relationships. This paper takes as its starting point that the situation of FSWs is better understood by including knowledge of the benefits of their intimate partnerships. Specifically, we employ the conceptual framework provided by emergent research examining intimacy as a complex fusion of affective and instrumental dimensions among sex workers. This perspective allows us to frame information about FSWs’ intimate partnerships within a behaviour-structural approach that is helpful for identifying how intimate partnerships can be a source of both benefit as well as increased risk to FSWs.
Gender is fundamental to understanding migration processes, causes and consequences, and gender and economic inequalities are critical to understanding why the HIV epidemic disproportionately burdens younger, poorer women worldwide. Yet the convergence of these phenomena has been poorly characterized, and is largely absent from the literature on migration and HIV. The central concern of this paper is to shed light on the ways in which gendered migration processes shape the HIV risks faced by female migrants, which in turn helps to explain the persistence of HIV in high prevalence areas.
While bacterial sexually transmitted infections (STIs) are important co- factors for HIV transmission, STI control has received little attention in recent years. The aim of this study was to assess STI treatment and HIV testing referral practices among health providers in Kenya.
Youth represent 40% of all new HIV infections in the world, 80% of which live in sub-Saharan Africa. Youth living with HIV (YLWH) are more likely to become lost to follow-up (LTFU) from care compared to all other age groups. This study explored the reasons for LTFU among YLWH in Kenya.
We estimated the 72-month efficacy of medical male circumcision (MMC) against herpes simplex virus 2 (HSV-2) incidence among men in the Kisumu MMC randomized trial.
To successfully develop and implement school-based sexual health interventions for adolescent girls, such as screening for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, it is important to understand parents’ and teachers’ attitudes towards sexual health education and acceptability of sexually transmitted infection (STI) screening interventions.
To more effectively control HIV epidemics, correlates of HIV infection need to be better understood, and prevention strategies adapted to account for risk patterns linked to particular settings or situations. Several factors have been associated with HIV infection in sub-Saharan Africa, including extramarital sex,1,2 multiple sexual partners,3–6 inconsistent or lack of condom use,7–10 the absence of male circumcision,11–13 and most recently, hormonal contraceptive use.14–16 Physiological factors, such as having a sexually transmitted infection (STI), particularly ulcerative genital diseases such as herpes simplex virus type 2 (HSV-2), have also been found to increase infectiousness and susceptibility to HIV infection via a variety of biological mechanisms.
Nyanza Province in western Kenya has the highest HIV prevalence of any province in Kenya. While HIV prevalence among adults aged 15–64 years decreased nationally from 7.2% in 2007 to 5.6% in 2012, prevalence in Nyanza Province slightly increased from 14.9 to 15.1% during this period.18 Similar to other African countries, women in Kenya are disproportionately affected by HIV. The 2012 Kenya AIDS Indicator Survey18 showed that among 15- to 64-year-olds, a higher proportion of women (6.9%) were infected with HIV than men (4.4%). A 2003 cross-sectional survey among 13–34-year-olds in rural Asembo, Nyanza Province, found an HIV prevalence of 3.5% among women 15–19 years of age compared to a prevalence of 1% among their male counterparts.6 Similarly, a gender disparity in prevalence was found among 20–24-year-olds (7.4% among women and 1.9% among men).
Given known challenges of undertaking HIV prevention research in resource-poor setting,20 and for specific populations such as adolescents,21,22 the availability of HIV prevalence and incidence estimates are important in designing and implementing HIV research or programmatic activities. The high prevalence of HIV in Nyanza Province makes it an ideal location to conduct research, including clinical trials, and to evaluate HIV biomedical interventions/strategies. Using data from the Kisumu Incidence Cohort Study (KICoS), one of the few detailed HIV risk factor incidence cohort studies in Kenya since the inception of the U.S. President’s Emergency Plan for AIDS Relief, we assessed the prevalence of HIV among young adults aged 16–34 for study eligibility and identified factors associated with HIV infection. The purpose of the analysis is to determine HIV prevalence and identify correlates of HIV infection among men and women residing in Kisumu.
There are 55 million orphaned children living in sub-Saharan Africa, a significant proportion of whom (27%) have been orphaned because of the HIV/AIDS epidemic. In Kenya, there are approximately 2.6 million orphans due to all causes, of whom 38% were orphaned due to AIDS, representing 12% of children aged <18 years in the country . Globally, young people aged 10–24 years accounted for 39% of all new HIV infections in 2012, with 72% of these cases occurring in sub-Saharan Africa . Orphaned children living in HIV endemic settings are at high risk of HIV infection, which may be associated with changes in caregiver and care environment.
HIV testing is the first step in linking HIV-positive adolescents to care and preventing new infections.However, the majority of adolescents are unaware of their HIV status . In Kenya, which represents 7% of all adolescent HIV infections globally, 49% of adolescents aged 15–19 years report ever testing for HIV, which is well below the target of 90%.Low uptake of HIV testing represents a missed opportunity for linkage to HIV care and prevention. Achieving new United Nations targets to ‘End Adolescent AIDS’ by 2020 will require improved understanding of how to engage adolescents in HIV testing and follow-up services.
Evidence suggests that Adolescent Girls and Young Women (AGYW) in Kenya experience high rates of HIV and other sexually transmitted infections (STIs), face poor sexual and reproductive health outcomes, and have challenges in accessing services. We aimed to better understand vulnerabilities at first sex among AGYW and young self-identified sex workers
Background: Adolescents make up 80% of the world population and despite being the hardest hit by sexual and reproductive health challenges their sexual and reproductive health (SRH) needs are largely unmet. The challenges are more intense among certain groups, including street adolescents based on social, cultural and biological factors.
Methods: A descriptive cross sectional study was carried out in Dagoretti district of Nairobi to determine the sexual and reproductive health behaviour risk factors among street adolescents. Data was collected through interviews from 195 adolescents and 10 key informants.
Results: The study established that despite moderately high SRH knowledge among 79% of the participants, 55% of them were involved in high risk sexual behaviour. Majority of the children had sex by the age of 10-15 years (41.9%) with older partners and did not use condoms (74.4%). In the multivariate model, the following factors were found to be predictive of risky sexual behaviour, male gender (pv=0.006), age in years (pv=0.037), attendance to HIV testing (pv=0.011), parents/guardians as a source of SRH information and combination of number of drugs used (pv=0.001).
Conclusion: This study recommends enactment of a comprehensive ASRH policy aimed at providing accurate, age-appropriate and comprehensive sexual and reproductive health education for all adolescents with specific focus on early adolescence (10yrs to 14yrs) and the male gender. It further recommends for the strengthening of parental involvement in peer education, integration of SRH and sensitization in drugs and substances of abuse and improvement of health centres as education and service provision centres on ASRH. Further studies are recommended to understand the gap between knowledge and practice as well as the need to disaggregate data on street children by cohorts to ensure appropriate programming for the different groups of children in contact with the streets.
The objectives of this study were to characterise the sexual health of street-connected adolescents in Eldoret, Kenya, analyse gender disparity of risks, estimate the prevalence of sexually transmitted infections (STIs), and identify factors associated with STIs.
Rates of pregnancy and HIV infection are high among adolescents. However, their engagement in prevention of mother-to-child HIV transmission (PMTCT) services is poorly characterized. We compared engagement in the PMTCT cascade between adult and adolescent mothers in Kenya.
Today's cohort of young people aged 10–24 years is the largest in history, with a population of over 1.8 billion, 90 percent of whom live in developing countries . Compared to the highly industrialized countries of the world, developing countries have a higher proportion of their population as young people [1,2] Furthermore, young people in developing countries have higher burden of diseases and higher mortality rates than those of high-income countries [3–5]. Of all regions of the world, sub-Saharan Africa has the highest disability-adjusted life years (DALYs) for the 10–24 years age group, followed by South East Asia
Early adolescence (ages 10–14) is a period of increased expectations for boys and girls to adhere to socially constructed and often stereotypical norms that perpetuate gender inequalities. The endorsement of such gender norms is closely linked to poor adolescent sexual and reproductive and other health-related outcomes yet little is known about the factors that influence young adolescents’ personal gender attitudes.
To explore factors that shape gender attitudes in early adolescence across different cultural settings globally.
A mixed-methods systematic review was conducted of the peer-reviewed literature in 12 databases from 1984–2014. Four reviewers screened the titles and abstracts of articles and reviewed full text articles in duplicate. Data extraction and quality assessments were conducted using standardized templates by study design. Thematic analysis was used to synthesize quantitative and qualitative data organized by the social-ecological framework (individual, interpersonal and community/societal-level factors influencing gender attitudes).
Eighty-two studies (46 quantitative, 31 qualitative, 5 mixed-methods) spanning 29 countries were included. Ninety percent of studies were from North America or Western Europe. The review findings indicate that young adolescents, across cultural settings, commonly express stereotypical or inequitable gender attitudes, and such attitudes appear to vary by individual sociodemographic characteristics (sex, race/ethnicity and immigration, social class, and age). Findings highlight that interpersonal influences (family and peers) are central influences on young adolescents’ construction of gender attitudes, and these gender socialization processes differ for boys and girls. The role of community factors (e.g. media) is less clear though there is some evidence that schools may reinforce stereotypical gender attitudes among young adolescents.
The findings from this review suggest that young adolescents in different cultural settings commonly endorse norms that perpetuate gender inequalities, and that parents and peers are especially central in shaping such attitudes. Programs to promote equitable gender attitudes thus need to move beyond a focus on individuals to target their interpersonal relationships and wider social environments. Such programs need to start early and be tailored to the unique needs of sub-populations of boys and girls. Longitudinal studies, particularly from low-and middle-income countries, are needed to better understand how gender attitudes unfold in adolescence and to identify the key points for intervention.
We examined the association between host factors present near the time of human immunodeficiency virus type 1 (HIV-1) acquisition and subsequent virus loads, in a prospective cohort study of women in Mombasa, Kenya. Women were prospectively followed monthly before HIV-1 infection. One hundred sixty-one commercial sex workers who became infected with HIV-1 were followed for a median of 34 months, and 991 plasma samples collected 4 months after infection were tested for HIV-1 RNA. The median virus set point at 4 months after infection was 4.46 log10 copies/mL, and the average virus load increase during subsequent
follow-up was 0.0094 log10 copies/mL/month. In a multivariate analysis that controlled for sexual behavior, the use of the injectable contraceptive depot medroxyprogesterone acetate (DMPA) at the time of HIV-1 infection was associated with a higher virus set point, and the presence of genital ulcer disease (GUD) during the early phase of HIV-1 infection was associated with greater change in virus load during follow-up. These findings suggest that, in women, the use of DMPA and the presence of GUD during the early phase of HIV- 1 infection may influence the natural course of infection
Cross-sectional analyses have demonstrated an association between use of hormonal contraceptives and shedding of herpes simplex virus (HSV). This prospective study evaluated the effect of initiating use of hormonal contraception on cervical HSV detection. Two hundred women who were seropositive for HSV-2 and human immunodeficiency virus (HIV) type 1 were examined for
cervical mucosal HSV by use of quantitative DNA polymerase chain reaction before and after beginning the use of hormonal contraceptives. Cervical HSV was detected in 32 women (16.0%) before initiating and in 25 women (12.5%) after initiating use of hormonal contraception (P ¼ .4). There were no significant differences in HSV shedding among the subgroups of women starting
combination oral contraceptives containing both estrogen and progesterone or progesteroneonly contraceptives. Among the 54 women who shed HSV at least once, the median change in cervical HSV after initiation of hormonal contraception was –313 copies/swab. In this prospective study, use of hormonal contraceptives did not increase detection of cervical HSV
MOST OF THE NEW HIV-1 INFECTIONS worldwide are contracted through heterosexual intercourse. Currently, almost
half of the new HIV-1 infections among adults are occurring in women.1 The male condom protects against acquisition of HIV-1 and other sexually transmitted diseases (STDs), but use of a male condom requires agreement by both sexual partners. The continued spread of HIV-1 and other STDs at high rates into many parts of the developing world, despite large-scale education campaigns and improvements in the distribution and availability of condoms, suggests a need to develop other, ideally female-controlled, methods of HIV-1 prevention
To determine the effect of circumcision status on acquisition of human immunodeficiency
virus (HIV) type 1 and other sexually transmitted diseases, a prospective cohort study of 746
HIV-1–seronegative trucking company employees was conducted in Mombasa, Kenya. During
the course of follow-up, 43 men acquired HIV-1 antibodies, yielding an annual incidence of
3.0%. The annual incidences of genital ulcers and urethritis were 4.2% and 15.5%, respectively.
In multivariate analysis, after controlling for demographic and behavioral variables, uncircumcised
status was an independent risk factor for HIV-1 infection (hazard rate ratio
[HRR] 5 4.0; 95% confidence interval [CI], 1.9–8.3) and genital ulcer disease (HRR 5 2.5; 95%
CI, 1.1–5.3). Circumcision status had no effect on the acquisition of urethral infections and
genital warts. In this prospective cohort of trucking company employees, uncircumcised status
was associated with increased risk of HIV-1 infection and genital ulcer disease, and these
effects remained after controlling for potential confounders.
Cervical and vaginal secretions from 17 women infected with human immunodeficiency virus type 1 (HIV-1) were evaluated daily through the course of one menstrual cycle for HIV-1 DNA (21-31 visits per woman). HIV-1-infected cells were detected in 207 (46%) of 450 end cervical swabs and 74 (16%) of 449 vaginal swabs. There was considerable variability in the percentage of positive swabs from each woman, ranging from 4% to 100% of end cervical swabs and from 0 to 71% of vaginal swabs. In multivariate analyses, plasma HIV-1 RNA was significantly associated with shedding of HIV-1-infected cells; each 1-unit increase in the log of plasma virus load was associated with a 5.6-fold increase in the odds of cervical shedding (95% confidence interval [CI], 2.1-14.8) and a 3.9-fold increase in the odds of vaginal shedding (95% CI, 2.1-7.2). There was no discernible pattern of genital tract shedding with phase of the menstrual cycle and no significant association with serum estradiol or progesterone levels.
There are many well-established reasons that support the rationale for integrating or linking
sexual and reproductive health (SRH) and HIV services in developing countries with generalized
HIV epidemics - primarily in sub-Saharan Africa. Yet the evidence base for the impact of
integrated service delivery on health outcomes and costs remains weak. Partly this is a result of
There is an emerging body of literature addressing the challenges of using randomized controlled
trials to assess the impact of public health interventions. Particularly in cases such as the Integra
Initiative, where the causal chain (between intervention and outcome) is long, and where there
are is a broad range of outcomes that need to be explored, and where there is already some a
degree of integration occurring in some clinic settings, attempting to conduct a randomized
controlled trial is not appropriate. Consistent with evaluation designs described by Habitat and
colleagues, the Integra design includes evaluation of performance and impact to try to make two
types of causal inference: adequacy and plausibility.
Evaluation of adequacy will assess whether the expected changes in provision, service utilization
and cost-effectiveness have occurred in intervention facilities. Evaluation of impact will assess
the plausibility that changes in service, health and behavioral outcomes are due to the Integra
Initiative. The case for such plausibility will be built from the following strands of evidence:
Comparing findings in 'intervention' facilities with those in facilities chosen as
'comparison' sites prior to the evaluation
Exploring a dose-response relationship between the measured extent of integration and
the study outcomes
Measuring changes in performance over time, to demonstrate a logical sequence between
the intervention (integration) and outcomes.
Measuring change in each step of the logic model - a prerequisite for any attribution to
Triangulating findings from a mix of research methods to capture a range of perspectives
and insights from different disciplines.
The study will employ a controlled pre- and post-test quasi-experimental, or non-randomized,
design and utilizes multiple research methods (cohort study, community survey, clinic
assessments, costing tools and qualitative interviews). Since the research is being conducted in
real-life health delivery settings where programmatic contamination is possible due to ongoing
health programme interventions over the study period, the control group will be referred to as a
'comparison group', for which outcomes will be compared over time up to two years after
This paper examines factors that may predispose unmarried and unemployed out-of-school youth to risky sexual behaviour. Data for analysis were derived from the Behaviour Surveillance Survey carried out in Kenya in late 2002. A total of 6129 male and female unmarried and unemployed out-of-school youth in the age range 15-24 years were successfully interviewed. However, for this paper only a sample of 3961 comprising sexually experienced youth in the 12 months preceding the survey was used. Methods of analysis included descriptive statistics and multinomial logistic regression. Results for males indicate that factors associated with low and high risk were whether they had fathered a child, district of residence and frequency of alcohol use, while current age and age at first sexual debut stood out for those with low risk alone. For females the district of residence and age of partner at sexual debut were the factors that predisposed them to low-risk sexual behaviour, while for high risk the district of residence, current age and ever being pregnant were significant. The results indicate that for these youth, contextual and probably social factors appear to be the main determinants of risky sexual behaviour for both males and females. The findings also support those of other studies that link risky sexual behaviour among youth, especially males, to alcohol consumption. Programmes for intervention therefore need to focus on these aspects. There is also a need for studies that can look at district-specific factors for more focused interventions. (author's)
There are many well-established reasons that support the rationale for integrating or linking sexual and reproductive health (SRH) and HIV services in developing countries with generalized HIV epidemics - primarily in sub-Saharan Africa. Yet the evidence base for the impact of integrated service delivery on health outcomes and costs remains weak. Partly this is a result of methodological difficulties.
There is an emerging body of literature addressing the challenges of using randomized controlled trials to assess the impact of public health interventions. Particularly in cases such as the Integra Initiative, where the causal chain (between intervention and outcome) is long, and where there are is a broad range of outcomes that need to be explored, and where there is already some a degree of integration occurring in some clinic settings, attempting to conduct a randomized controlled trial is not appropriate. Consistent with evaluation designs described by Habitat and colleagues, the Integra design includes evaluation of performance and impact to try to make two types of causal inference: adequacy and plausibility.
Evaluation of adequacy will assess whether the expected changes in provision, service utilization and cost-effectiveness have occurred in intervention facilities. Evaluation of impact will assess the plausibility that changes in service, health and behavioral outcomes are due to the Integra Initiative. The case for such plausibility will be built from the following strands of evidence:
• Comparing findings in 'intervention' facilities with those in facilities chosen as 'comparison' sites prior to the evaluation
• Exploring a dose-response relationship between the measured extent of integration and the study outcomes
• Measuring changes in performance over time, to demonstrate a logical sequence between the intervention (integration) and outcomes.
• Measuring change in each step of the logic model - a prerequisite for any attribution to the intervention
• Triangulating findings from a mix of research methods to capture a range of perspectives and insights from different disciplines.
The study will employ a controlled pre- and post-test quasi-experimental, or non-randomized, design and utilizes multiple research methods (cohort study, community survey, clinic assessments, costing tools and qualitative interviews). Since the research is being conducted in real-life health delivery settings where programmatic contamination is possible due to ongoing health programme interventions over the study period, the control group will be referred to as a 'comparison group', for which outcomes will be compared over time up to two years after implementation.
Male circumcision (MC) reduces, by more than half, the risk of HIV-1 acquisition. WHO and UNAIDS recommend that "male circumcision should be recognized as an efficacious intervention for HIV prevention especially in countries and regions with heterosexual HIV epidemics and low male circumcision prevalence." As a result, programs have been introduced and scaled up for voluntary medical male circumcision. Kenya leads with the largest expansion of services.
Early resumption of sexual intercourse after MC may have deleterious effects, including higher rates of post-operative surgical complications, and higher HIV acquisition among females in couples that resume sexual activity before certified wound healing. In the context of rapid scale-up of MC, adherence to post-operative clinic appointments allows clinicians to assess wound healing and to deliver risk reduction counseling. Abstinence from sexual intercourse before complete wound healing would reduce the rate of post-operative adverse events and minimize the risk of HIV transmission from HIV-infected men to their uninfected female partners.
To the investigators knowledge, the effect of reminders delivered via text messaging to promote adherence to clinic visits and abstinence after MC has not been investigated. The investigators propose a randomized controlled trial in which men who will have undergone voluntary medical male circumcision at selected sites in Kisumu will be randomized to receive either the intervention (context-sensitive text messages after circumcision) or the control condition (usual care). This study seeks to determine (a) the effect of regular text messages sent to men after circumcision on attendance of the scheduled 7-day post-operative clinic visit versus usual care; (b) the proportion of men who resume sexual activity before 42 days post-procedure after receiving regular text messages versus usual care within the 42 days post-circumcision; and (c) to identify potential predictors of failure to attend the scheduled 7-day post-operative visit and early resumption of sexual intercourse.