A hybrid mobile approach for population-wide HIV testing in rural east Africa: an observational study.

BACKGROUND: Despite large investments in HIV testing, only an estimated 45% of HIV-infected people in sub-Saharan Africa know their HIV status. Optimum methods for maximising population-level testing remain unknown. We sought to show the effectiveness of a hybrid mobile HIV testing approach at achieving population-wide testing coverage. METHODS: We enumerated adult (≥15 years) residents of 32 communities in Uganda (n=20) and Kenya (n=12) using a door-to-door census. Stable residence was defined as living in the community for at least 6 months in the past year. In each community, we did 2 week multiple-disease community health campaigns (CHCs) that included HIV testing, counselling, and referral to care if HIV infected; people who did not participate in the CHCs were approached for home-based testing (HBT) for 1-2 months within the 1-6 months after the CHC. We measured population HIV testing coverage and predictors of testing via HBT rather than CHC and non-testing. FINDINGS: From April 2, 2013, to June 8, 2014, 168,772 adult residents were enumerated in the door-to-door census. HIV testing was achieved in 131,307 (89%) of 146,906 adults with stable residence. 13,043 of 136,033 (9·6%, 95% CI 9·4-9·8) adults with and without stable residence had HIV; median CD4 count was 514 cells per µL (IQR 355-703). Among 131,307 adults with stable residence tested, 56,106 (43%) reported no previous testing. Among 13,043 HIV-infected adults, 4932 (38%) were unaware of their status. Among 105,170 CHC attendees with stable residence 104,635 (99%) accepted HIV testing. Of 131,307 adults with stable residence tested, 104,635 (80%; range 60-93% across communities) tested via CHCs. In multivariable analyses of adults with stable residence, predictors of non-testing included being male (risk ratio [RR] 1·52, 95% CI 1·48-1·56), single marital status (1·70, 1·66-1·75), age 30-39 years (1·58, 1·52-1·65 vs 15-19 years), residence in Kenya (1·46, 1·41-1·50), and migration out of the community for at least 1 month in the past year (1·60, 1·53-1·68). Compared with unemployed people, testing for HIV was more common among farmers (RR 0·73, 95% CI 0·67-0·79) and students (0·73, 0·69-0·77); and compared with people with no education, testing was more common in those with primary education (0·84, 0·80-0·89). INTERPRETATION: A hybrid, mobile approach of multiple-disease CHCs followed by HBT allowed for flexibility at the community and individual level to help reach testing coverage goals. Men and mobile populations remain challenges for universal testing. FUNDING: National Institutes of Health and President's Emergency Plan for AIDS Relief.

Integrating family planning into HIV care in western Kenya: HIV care providers' perspectives and experiences one year following integration.

With high rates of unintended pregnancy in sub-Saharan Africa, integration of family planning (FP) into HIV care is being explored as a strategy to reduce unmet need for contraception. Perspectives and experiences of healthcare providers are critical in order to create sustainable models of integrated care. This qualitative study offers insight into how HIV care providers view and experience the benefits and challenges of providing integrated FP/HIV services in Nyanza Province, Kenya. Sixteen individual interviews were conducted among healthcare workers at six public sector HIV care facilities one year after the implementation of integrated FP and HIV services. Data were transcribed and analyzed qualitatively using grounded theory methods and Atlas.ti. Providers reported a number of benefits of integrated services that they believed increased the uptake and continuation of contraceptive methods. They felt that integrated services enabled them to reach a larger number of female and male patients and in a more efficient way for patients compared to non-integrated services. Availability of FP services in the same place as HIV care also eliminated the need for most referrals, which many providers saw as a barrier for patients seeking FP. Providers reported many challenges to providing integrated services, including the lack of space, time, and sufficient staff, inadequate training, and commodity shortages. Despite these challenges, the vast majority of providers was supportive of FP/HIV integration and found integrated services to be beneficial to HIV-infected patients. Providers' concerns relating to staffing, infrastructure, and training need to be addressed in order to create sustainable, cost-effective FP/HIV integrated service models.

Shamba Maisha: randomized controlled trial of an agricultural and finance intervention to improve HIV health outcomes.

OBJECTIVES: Food insecurity and HIV/AIDS outcomes are inextricably linked in sub-Saharan Africa. We report on health and nutritional outcomes of a multisectoral agricultural intervention trial among HIV-infected adults in rural Kenya. DESIGN: This is a pilot cluster randomized controlled trial. METHODS: The intervention included a human-powered water pump, a microfinance loan to purchase farm commodities, and education in sustainable farming practices and financial management. Two health facilities in Nyanza Region, Kenya were randomly assigned as intervention or control. HIV-infected adults 18 to 49 years' old who were on antiretroviral therapy and had access to surface water and land were enrolled beginning in April 2012 and followed quarterly for 1 year. Data were collected on nutritional parameters, CD4 T-lymphocyte counts, and HIV RNA. Differences in fixed-effects regression models were used to test whether patterns in health outcomes differed over time from baseline between the intervention and control arms. RESULTS: We enrolled 72 and 68 participants in the intervention and control groups, respectively. At 12 months follow-up, we found a statistically significant increase in CD4 cell counts (165 cells/µl, P < 0.001) and proportion virologically suppressed in the intervention arm compared with the control arm (comparative improvement in proportion of 0.33 suppressed, odds ratio 7.6, 95% confidence interval: 2.2-26.8). Intervention participants experienced significant improvements in food security (3.6 scale points higher, P < 0.001) and frequency of food consumption (9.4 times per week greater frequency, P = 0.013) compared to controls. CONCLUSION: Livelihood interventions may be a promising approach to tackle the intersecting problems of food insecurity, poverty and HIV/AIDS morbidity.

Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial.

BACKGROUND: Despite advances in treatment of people living with HIV, morbidity and mortality remains unacceptably high in sub-Saharan Africa, largely due to parallel epidemics of poverty and food insecurity. METHODS/DESIGN: We conducted a pilot cluster randomized controlled trial (RCT) of a multisectoral agricultural and microfinance intervention (entitled Shamba Maisha) designed to improve food security, household wealth, HIV clinical outcomes and women's empowerment. The intervention was carried out at two HIV clinics in Kenya, one randomized to the intervention arm and one to the control arm. HIV-infected patients >18 years, on antiretroviral therapy, with moderate/severe food insecurity and/or body mass index (BMI) <18.5, and access to land and surface water were eligible for enrollment. The intervention included: 1) a microfinance loan (~$150) to purchase the farming commodities, 2) a micro-irrigation pump, seeds, and fertilizer, and 3) trainings in sustainable agricultural practices and financial literacy. Enrollment of 140 participants took four months, and the screening-to-enrollment ratio was similar between arms. We followed participants for 12 months and conducted structured questionnaires. We also conducted a process evaluation with participants and stakeholders 3-5 months after study start and at study end. DISCUSSION: Baseline results revealed that participants at the two sites were similar in age, gender and marital status. A greater proportion of participants at the intervention site had a low BMI in comparison to participants at the control site (18% vs. 7%, p = 0.054). While median CD4 count was similar between arms, a greater proportion of participants enrolled at the intervention arm had a detectable HIV viral load compared with control participants (49% vs. 28%, respectively, p < 0.010). Process evaluation findings suggested that Shamba Maisha had high acceptability in recruitment, delivered strong agricultural and financial training, and led to labor saving due to use of the water pump. Implementation challenges included participant concerns about repaying loans, agricultural challenges due to weather patterns, and a challenging partnership with the microfinance institution. We expect the results from this pilot study to provide useful data on the impacts of livelihood interventions and will help in the design of a definitive cluster RCT. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov, NCT01548599.

Implementation and Operational Research: Effects of Antenatal Care and HIV Treatment Integration on Elements of the PMTCT Cascade: Results From the SHAIP Cluster-Randomized Controlled Trial in Kenya.

BACKGROUND: Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. This study aimed to determine whether integration of HIV services into ANC settings improves PMTCT service utilization outcomes. METHODS: ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or nonintegrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), whereas control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. RESULTS: HIV care enrollment was higher in intervention compared with control clinics [69% versus 36%; odds ratio = 3.94, 95% confidence interval (CI): 1.14 to 13.63]. Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, hazard ratio = 2.20, 95% CI: 1.62 to 3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%; odds ratio = 3.22, 95% CI: 1.81 to 5.72). Infant testing was more common in the intervention arm (25% versus 18%), however, not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. CONCLUSIONS: Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions.

Implementation and Operational Research: Effect of Integration of HIV Care and Treatment Into Antenatal Care Clinics on Mother-to-Child HIV Transmission and Maternal Outcomes in Nyanza, Kenya: Results From the SHAIP Cluster Randomized Controlled Trial.

BACKGROUND: Many HIV-infected pregnant women identified during antenatal care (ANC) do not enroll in long-term HIV care, resulting in deterioration of maternal health and continued risk of HIV transmission to infants. METHODS: We performed a cluster randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya. Twelve facilities were randomized to provide either integrated services (ANC, prevention of mother-to-child transmission, and HIV care delivered in the ANC clinic; n = 6 intervention facilities) or standard ANC services (including prevention of mother-to-child transmission and referral to a separate clinic for HIV care; n = 6 control facilities). RESULTS: There were high patient attrition rates over the course of this study. Among study participants who enrolled in HIV care, there was 12-month follow-up data for 256 of 611 (41.8%) women and postpartum data for only 325 of 1172 (28%) women. By 9 months of age, 382 of 568 (67.3%) infants at intervention sites and 338 of 594 (57.0%) at control sites had tested for HIV [odds ratio (OR) 1.45, 95% confidence interval (CI): 0.71 to 2.82]; 7.3% of infants tested HIV positive at intervention sites compared with 8.0% of infants at control sites (OR 0.89, 95% CI: 0.56 to 1.43). The composite clinical/immunologic progression into AIDS was similar in both arms (4.9% vs. 5.1%, OR 0.83, 95% CI: 0.41 to 1.68). CONCLUSIONS: Despite the provision of integrated services, patient attrition was substantial in both arms, suggesting barriers beyond lack of service integration. Integration of HIV services into the ANC clinic was not associated with a reduced risk of HIV transmission to infants and did not appear to affect short-term maternal health outcomes.

Integrating family planning and HIV services in western Kenya: the impact on HIV-infected patients' knowledge of family planning and male attitudes toward family planning.

Little information exists on the impact of integrating family planning (FP) services into HIV care and treatment on patients' familiarity with and attitudes toward FP. We conducted a cluster-randomized trial in 18 public HIV clinics with 12 randomized to integrated FP and HIV services and 6 to the standard referral-based system where patients are referred to an FP clinic. Serial cross-sectional surveys were done before (n = 488 women, 486 men) and after (n = 479 women, 481 men) the intervention to compare changes in familiarity with FP methods and attitudes toward FP between integrated and nonintegrated (NI) sites. We created an FP familiarity score based on the number of more effective FP methods patients could identify (score range: 0-6). Generalized estimating equations were used to control for clustering within sites. An increase in mean familiarity score between baseline (mean = 5.16) and post-intervention (mean = 5.46) occurred with an overall mean change of 0.26 (95% confidence intervals [CI] = 0.09, 0.45; p = 0.003) across all sites. At end line, there was no difference in increase of mean FP familiarity scores at intervention versus control sites (mean = 5.41 vs. 5.49, p = 0.94). We observed a relative decrease in the proportion of males agreeing that FP was "women's business" at integrated sites (baseline 42% to end line 30%; reduction of 12%) compared to males at NI sites (baseline 35% to end line 42%; increase of 7%; adjusted odds ration [aOR] = 0.43; 95% CI = 0.22, 0.85). Following FP-HIV integration, familiarity with FP methods increased but did not differ by study arm. Integration was associated with a decrease in negative attitudes toward FP among men.

Providers' perspectives on male involvement in family planning in the context of a cluster-randomized controlled trial evaluating integrating family planning into HIV care in Nyanza Province, Kenya.

Integration of family planning (FP) services into HIV care and increasing male partner involvement in FP are being explored as strategies to reduce unmet need for contraception. Providers' views can give valuable insight into current FP care. We evaluated the perspectives of HIV care providers working at HIV clinics in Nyanza Province, Kenya, on male partner involvement in FP. This qualitative study was part of a cluster-randomized controlled trial evaluating the impact of integrating FP into HIV services on contraceptive prevalence among HIV-positive patients in Nyanza Province, Kenya. Thirty individual interviews were conducted among health-care workers at 11 HIV care facilities in Nyanza Province, Kenya. Interviews were conducted from integrated and control sites one year after implementation of FP/HIV integration. Data were transcribed and analyzed using grounded theory methods and ATLAS-ti. Providers supported male partner inclusion when choosing FP and emphasized that decisions should be made collaboratively. Providers believed that men have traditionally played a prohibitive role in FP but identified several benefits to partner involvement in FP decision-making including: reducing relationship conflicts, improving FP knowledge and contraceptive continuation, and increasing partner cohesion. Providers suggested that integrated FP/HIV services facilitate male partner involvement in FP decision-making since HIV-positive men are already established patients in HIV clinics. Some providers stated that women had a right to choose and start FP alone if their partners did not agree with using FP. Integrated FP services may be a useful strategy to help increase male participation to reduce the unmet FP need in sub-Saharan Africa. It is important to determine effective ways to engage male partners in FP, without impinging upon women's autonomy and reproductive rights.

HIV-positive men's experiences with integrated family planning and HIV services in western Kenya: integration fosters male involvement.

A growing body of evidence indicates that integrating family planning (FP) services into HIV care is effective at improving contraceptive uptake among HIV-positive women in resource-poor settings, yet little research has examined HIV-positive men's experiences with such integration. We conducted in-depth interviews with 21 HIV-positive men seeking care at HIV clinics in Nyanza, Kenya. All clinics were intervention sites for a FP/HIV service integration cluster-randomized trial. Grounded theory was used to code and analyze the data. Our findings highlight men's motivations for FP, reasons why men prefer obtaining their FP services, which include education, counseling, and commodities, at HIV care clinics, and specific ways in which integrated FP/HIV services fostered male inclusion in FP decision-making. In conclusion, men appear invested in FP and their inclusion in FP decision-making may bolster both female and male agency. Men's positive attitudes towards FP being provided at HIV care clinics supports the programmatic push towards integrated delivery models for FP and HIV services.

Impact of family planning health talks by lay health workers on contraceptive knowledge and attitudes among HIV-infected patients in rural Kenya.

OBJECTIVE: To determine if a health talk on family planning (FP) by community clinic health assistants (CCHAs) will improve knowledge, attitudes and behavioral intentions about contraception in HIV-infected individuals. METHODS: A 15-min FP health talk was given by CCHAs in six rural HIV clinics to a sample of 49 HIV-infected men and women. Effects of the health talk were assessed through a questionnaire administered before the health talk and after completion of the participant's clinic visit. RESULTS: Following the health talk, there was a significant increase in knowledge about contraceptives (p<.0001), side-effects (p<.0001), and method-specific knowledge about IUCDs (p<.001), implants (p<.0001), and injectables (p<.05). Out of 31 women and 18 men enrolled, 14 (45%) women and 6 (33%) men intended to try a new contraceptive. Participant attitudes toward FP were high before and after the health talk (median 4 of 4). CONCLUSION: A health talk delivered by CCHAs can increase knowledge of contraception and promote the intention to try new more effective contraception among HIV-infected individuals. PRACTICE IMPLICATIONS: FP health talks administered by lay-health providers to HIV-infected individuals as they wait for HIV services can influence FP knowledge and intention to use FP.

Integration of family planning services into HIV care and treatment in Kenya: a cluster-randomized trial.

OBJECTIVE: To determine whether integrating family planning services into HIV care is associated with increased use of more effective contraceptive methods (sterilization, intrauterine device, implant, injectable or oral contraceptives). DESIGN: Cluster-randomized trial. SETTING: Eighteen public HIV clinics in Nyanza Province, Kenya. PARTICIPANTS: Women aged 18-45 years receiving care at participating HIV clinics; 5682 clinical encounters from baseline period (December 2009-February 2010) and 12,531 encounters from end-line period (July 2011-September 2011, 1 year after site training). INTERVENTION: Twelve sites were randomized to integrate family planning services into the HIV clinic, whereas six clinics were controls where clients desiring contraception were referred to family planning clinics at the same facility. MAIN OUTCOME MEASURES: Increase in use of more effective contraceptive methods between baseline and end-line periods. Pregnancy rates during the follow-up year (October 2010-September 2011) were also compared. RESULTS: Women seen at integrated sites were significantly more likely to use more effective contraceptive methods at the end of the study [increased from 16.7 to 36.6% at integrated sites, compared to increase from 21.1 to 29.8% at controls; odds ratio (OR) 1.81, 95% confidence interval (CI) 1.24-2.63]. Condom use decreased non-significantly at intervention sites compared to controls (OR 0.64, 95% CI 0.35-1.19). No difference was observed in incident pregnancy in the first year after integration comparing intervention to control sites (incidence rate ratio 0.90; 95% CI 0.68-1.20). CONCLUSIONS: Integration of family planning services into HIV care clinics increased use of more effective contraceptive methods with a non-significant reduction in condom use. Although no significant reduction in pregnancy incidence was observed during the study, 1 year may be too short a period of observation for this outcome.

Cost, cost-efficiency and cost-effectiveness of integrated family planning and HIV services.

OBJECTIVE: To evaluate costs, cost-efficiency and cost-effectiveness of integration of family planning into HIV services. INTERVENTION: Integration of family planning services into HIV care and treatment clinics. DESIGN: A cluster-randomized trial. SETTING: Twelve health facilities in Nyanza, Kenya were randomized to integrate family planning into HIV care and treatment; six health facilities were randomized to (nonintegrated) standard-of-care with separately delivered family planning and HIV services. MAIN OUTCOME MEASURES: We assessed costs, cost-efficiency (cost per additional use of more effective family planning), and cost-effectiveness (cost per pregnancy averted) associated with the first year of integration of family planning into HIV care. More effective family planning methods included oral and injectable contraceptives, subdermal implants, intrauterine device, and female and male sterilization. PATIENTS AND PARTICIPANTS: We collected cost data through interviews with study staff and review of financial records to determine costs of service integration. RESULTS: Integration of services was associated with an average marginal cost of $841 per site and $48 per female patient. Average overall and marginal costs of integration were associated with personnel costs [initial ($1003 vs. $872) and refresher ($498 vs. $330) training, mentoring ($1175 vs. $902) and supervision ($1694 vs. $1636)], with fewer resources required for other fixed ($18 vs. $0) and recurring expenses ($471 vs. $287). Integration was associated with a marginal cost of $65 for each additional use of more effective family planning and $1368 for each pregnancy averted. CONCLUSION: Integration of family planning and HIV services is feasible, inexpensive to implement, and cost-efficient in the Kenyan setting, and thus supports current Kenyan integration policy.

Does integrating family planning into HIV care and treatment impact intention to use contraception? Patient perspectives from HIV-infected individuals in Nyanza Province, Kenya.

OBJECTIVE: To evaluate whether HIV-infected women and men in HIV care and not using highly effective methods of contraception thought they would be more likely to use contraception if it were available at the HIV clinic. METHODS: A face-to-face survey assessing family-planning knowledge, attitudes, and practices was conducted among 976 HIV-infected women and men at 18 public-sector HIV clinics in Nyanza, Kenya. Data were analyzed using logistic regression and generalized estimating equations. RESULTS: The majority of women (73%) and men (71%) thought that they or their partner would be more likely to use family planning if it were offered at the HIV clinic. In multivariable analysis, women who reported making family-planning decisions with their partner (adjusted odds ratio [aOR] 3.22; 95% confidence interval [CI], 1.53-6.80) and women aged 18-25 years who were not currently using family planning (aOR 4.76; 95% CI, 2.28-9.95) were more likely to think they would use contraception if integrated services were available. Women who perceived themselves to be infertile (aOR 0.07; 95% CI, 0.02-0.31) and had access to a cell phone (aOR 0.40; 95% CI, 0.25-0.63) were less likely to think that integrated services would change their contraceptive use. Men who were not taking antiretroviral medications (aOR 3.30; 95% CI, 1.49-7.29) were more likely, and men who were unsure of their partner's desired number of children (aOR 0.36; 95% CI, 0.17-0.76), were not currently using family planning (aOR 0.40; 95% CI, 0.22-0.73), and were living in a peri-urban setting (aOR 0.46; 95% CI, 0.21-0.99) were less likely to think their partner would use contraception if available at the HIV clinic. CONCLUSIONS: Integrating family planning into HIV care would probably have a broad impact on the majority of women and men accessing HIV care and treatment. Integrated services would offer the opportunity to involve men more actively in the contraceptive decision-making process, potentially addressing 2 barriers to family planning: access to contraception and partner uncertainty or opposition.

Overcoming Barriers to Family Planning through Integration: Perspectives of HIV-Positive Men in Nyanza Province, Kenya.

This study explored barriers to and facilitators of using family planning services among HIV-positive men in Nyanza Province, Kenya. From May to June 2010, in-depth interviews were conducted with 30 men receiving care at 15 HIV clinics. The key barriers to the use of family planning included concerns about side effects of contraceptives, lack of knowledge about contraceptive methods, myths and misconceptions including fear of infertility, structural barriers such as staffing shortages at HIV clinics, and a lack of male focus in family planning methods and service delivery. The integration of family planning into HIV clinics including family planning counseling and education was cited as an important strategy to improve family planning receptivity among men. Integrating family planning into HIV services is a promising strategy to facilitate male involvement in family planning. Integration needs to be rigorously evaluated in order to measure its impact on unmet need for contraception among HIV-positive women and their partners and assure that it is implemented in a manner that engages both men and women.

The study of HIV and antenatal care integration in pregnancy in Kenya: design, methods, and baseline results of a cluster-randomized controlled trial.

BACKGROUND: Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma. METHODOLOGY/PRINCIPAL FINDINGS: A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009- March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines. CONCLUSIONS/SIGNIFICANCE: This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving to eliminate vertical transmission of HIV and improve maternal health. TRIAL REGISTRATION: ClinicalTrials.gov NCT00931216 http://clinicaltrials.gov/ct2/show/NCT00931216.