Improving viral load utilisation to enhance care for Kenyan adolescents with HIV.

Improving the use of viral load (VL) testing for adolescents and young people living with HIV (AYPLWH) is a priority for Kenya's Ministry of Health (MOH). Despite expansion of VL testing coverage and rollout of national policies, guidelines and training, VL result utilisation for AYPLWH remains suboptimal, with inadequate adherence to national guidelines recommending everyone on antiretroviral therapy (ART) with unsuppressed viral load (UVL) (≥401 copies/mL) receive three enhanced adherence counselling (EAC) sessions and a repeat VL test within 3 months. In March 2019, ICAP at Columbia University partnered with the MOH to launch a Quality Improvement Collaborative (QIC) at 22 health facilities in the Eastern Province to optimise management of AYPLWH on ART with UVL. Over 17 months, facility QI teams tested interventions targeting client education, workflow modifications, commodity management, community engagement and improved documentation. The QIC led to marked improvement in the proportion of clients completing three EAC sessions and repeat VL testing. Median completion rate was 16% (n=479) at baseline (from March 2018 to February 2019) and rose to 73% (n=755) during the implementation period (from March 2019 to July 2020). In the final month (July 2020), rates rose to 90% (n=31). Another success was the increase in the proportion of clients whose VL was resuppressed on repeat testing, which improved from 34% (n=273) at baseline to 62% (n=710) during the implementation period and 77% (n=44) in the final month. The QIC also led to improvement in the proportion of AYPLWH on first-line ART whose regimens were switched within 2 months of recorded UVL results, which rose from 58% (n=48) at baseline to 94% (n=128) during the implementation period. In summary, the QIC helped facility teams to identify and prioritise local, contextually appropriate innovations which led to swift improvement in three critical indicators of VL utilisation.

Group antenatal care for improving retention of adolescent and young pregnant women living with HIV in Kenya.

BACKGROUND: Pregnant and breastfeeding adolescents and young women living with HIV (AYWLH) have lower retention in prevention of mother-to-child transmission (PMTCT) services compared to older women. METHODS: We evaluated a differentiated service model for pregnant and postnatal AYWLH at seven health facilities in western Kenya aimed at improving retention in antiretroviral treatment (ART) services. All pregnant AYWLH < 25 years presenting for antenatal care (ANC) were invited to participate in group ANC visits including self-care and peer-led support sessions conducted by health facility nurses per national guidelines. ART register data were used to assess loss to follow-up (LTFU) among newly-enrolled pregnant adolescent (< 20 years) and young women (20-24 years) living with HIV starting ART in the pre-period (January-December 2016) and post-period (during implementation; December 2017-January 2019). Poisson regression models compared LTFU incidence rate ratios (IRR) in the first six months after PMTCT enrollment and risk ratios compared uptake of six week testing for HIV-exposed infants (HEI) between the pre- and post-periods. RESULTS: In the pre-period, 223 (63.2%) of 353 pregnant AYWLH newly enrolled in ANC had ART data, while 320 (71.1%) of 450 in the post-period had ART data (p = 0.02). A higher proportion of women in the post-period (62.8%) had known HIV-positive status at first ANC visit compared to 49.3% in the pre-period (p < 0.001). Among pregnant AYWLH < 20 years, the incidence rate of LTFU in the first six months after enrollment in ANC services declined from 2.36 per 100 person months (95%CI 1.06-5.25) in the pre-period to 1.41 per 100 person months (95%CI 0.53-3.77) in the post-period. In both univariable and multivariable analysis, AYWLH < 20 years in the post-period were almost 40% less likely to be LTFU compared to the pre-period, although this finding did not meet the threshold for statistical significance (adjusted incidence rate ratio 0.62, 95%CI 0.38-1.01, p = 0.057). Testing for HEI was 10% higher overall in the post-period (adjusted risk ratio 1.10, 95%CI 1.01-1.21, p = 0.04). CONCLUSIONS: Interventions are urgently needed to improve outcomes among pregnant and postnatal AYWLH. We observed a trend towards increased retention among pregnant adolescents during our intervention and a statistically significant increase in uptake of six week HEI testing.

Effects of the Coronavirus Disease 2019 Pandemic on Human Immunodeficiency Virus Services: Findings from 11 Sub-Saharan African Countries.

BACKGROUND: Due to concerns about the effects of the coronavirus disease 2019 (COVID-19 pandemic on health services, we examined its effects on human immunodeficiency virus (HIV) services in sub-Saharan Africa. METHODS: Quarterly data (Q1, 10/2019-12/2019; Q2, 1/2020-3/2020; Q3, 4/2020-6/2020; Q4, 7/2020-9/2020) from 1059 health facilities in 11 countries were analyzed and categorized by stringency of pandemic measures. We conducted a difference-in-differences assessment of HIV service changes from Q1-Q2 to Q3-Q4 by higher vs lower stringency. RESULTS: There was a 3.3% decrease in the number HIV tested from Q2 to Q3 (572 845 to 553 780), with the number testing HIV-positive declining by 4.9% from Q2 to Q3. From Q3 to Q4, the number tested increased by 10.6% (612 646), with an increase of 8.8% (23 457) in the number testing HIV-positive with similar yield (3.8%). New antiretroviral therapy (ART) initiations declined by 9.8% from Q2 to Q3 but increased in Q4 by 9.8%. Across all quarters, the number on ART increased (Q1, 419 028 to Q4, 476 010). The number receiving viral load (VL) testing in the prior 12 months increased (Q1, 255 290 to Q4, 312 869). No decrease was noted in VL suppression (Q1, 87.5% to Q4, 90.1%). HIV testing (P < .0001) and new ART initiations (P = .001) were inversely associated with stringency. CONCLUSIONS: After initial declines, rebound was brisk, with increases noted in the number HIV tested, newly initiated or currently on ART, VL testing, and VL suppression throughout the period, demonstrating HIV program resilience in the face of the COVID-19 crisis.

Life in the Balance: Young Female Sex Workers in Kenya Weigh the Risks of COVID-19 and HIV.

The COVID-19 pandemic has had serious health, economic and psychosocial consequences. Marginalized populations including female sex workers face the stark choice of risking exposure to SARS-CoV-2 as they engage with clients or prioritizing their health at the cost of losing a primary source of income. As part of an ongoing open-label, randomized controlled trial providing daily oral pre-exposure prophylaxis and adherence support, we interviewed 193 of 200 enrolled young female sex workers (18-24 years) in Kisumu, Kenya, about COVID-19 awareness and precautions, access to health services, and sex work during Kenya's pandemic-related lockdown. Nearly all participants were aware of COVID-19 and reported taking protective measures, but only half reported concerns about acquiring SARS-CoV-2. Night curfews and bar closures adversely affected participants' sex work business, reducing the number of clients and payment amounts from clients. Nearly 15% experienced violence from a client or regular, non-paying sex partner during the lockdown period. Participants' access to healthcare services was not disrupted.

RESUMEN: La pandemia de COVID-19 puede tener graves consecuencias sanitarias, económicas y psicosociales. Poblaciones marginadas como las mujeres trabajadoras sexuales se enfrentan a la dura elección de arriesgarse a exponerse al SARS-CoV-2 mientras interactúan con los clientes o priorizar su salud a riesgo de perder su principal fuente de ingresos. Como parte de un ensayo controlado aleatorio abierto en curso que proporcionaba profilaxis pre-exposición (PrEP) oral diaria y apoyo para la adherencia, entrevistamos a 193 de 200 las mujeres trabajadoras sexuales jóvenes (de 18 a 24 años) en Kisumu, Kenia, sobre su conocimiento y precauciones frente al COVID-19, acceso a servicios de salud, y trabajo sexual durante el confinamiento por la pandemia en Kenia. Casi todas las participantes conocían el COVID-19 y reportaron que tomaron medidas de protección, pero sólo la mitad dijeron estar preocupadas por infectarse con el SARS-CoV-2. Los toques de queda nocturnos y los cierres de bares afectaron negativamente al negocio del trabajo sexual, reduciendo el número de clientes y la cantidad que recibieron de los clientes. Casi el 15% experimentó violencia por parte de un cliente o por una pareja sexual habitual que no paga durante el periodo de confinamiento. El acceso de las participantes a los servicios de salud no se vio interrumpido.

Changes in D-dimer after initiation of antiretroviral therapy in adults living with HIV in Kenya.

BACKGROUND: Increased coagulation biomarkers are associated with poor outcomes among people living with HIV (PLHIV). There are few data available from African cohorts demonstrating the effect of antiretroviral therapy (ART) on coagulation biomarkers. METHODS: From March 2014 to October 2014, ART-naïve PLHIV initiating non-nucleoside reverse transcriptase inhibitor-based ART were recruited from seven clinics in western Kenya and followed for up to 12 months. Demographics, clinical history and blood specimens were collected. Logistic regression models adjusted for intrasite clustering examined associations between HIV viral load and D-Dimer at baseline. Mixed linear effects models were used to estimate mean change from baseline to 6 months overall, and by baseline viral load, sex and TB status at enrollment. Mean change in D-dimer at 6 months is reported on the log10 scale and as percentage change from baseline. RESULTS: Among 611 PLHIV enrolled, 66% were female, median age was 34 years (interquartile range (IQR) 29-43 years), 31 (5%) participants had tuberculosis and median viral load was 113,500 copies/mL (IQR: 23,600-399,000). At baseline, 311 (50.9%) PLHIV had elevated D-dimer (> 500 ng/mL) and median D-dimer was 516.4 ng/mL (IQR: 302.7-926.6) (log baseline D-dimer: 2.7, IQR: 2.5-3.0). Higher baseline D-dimer was significantly associated with higher viral load (p < 0.0001), female sex (p = 0.02) and tuberculosis (p = 0.02). After 6 months on ART, 518 (84.8%) PLHIV had achieved viral load < 1000 copies/mL and median D-dimer was 390.0 (IQR: 236.6-656.9) (log D-dimer: 2.6, IQR: 2.4-2.8). Mean change in log D-dimer from baseline to 6 months was - 0.12 (95%CI -0.15, - 0.09) (p < 0.0001) indicating at 31.3% decline (95%CI -40.0, - 23.0) in D-dimer levels over the first 6 months on ART. D-dimer decline after ART initiation was significantly greater among PLHIV with tuberculosis at treatment initiation (- 172.1, 95%CI -259.0, - 106.3; p < 0.0001) and those with log viral load > 6.0 copies/mL (- 91.1, 95%CI -136.7, - 54.2; p < 0.01). CONCLUSIONS: In this large Kenyan cohort of PLHIV, women, those with tuberculosis and higher viral load had elevated baseline D-dimer. ART initiation and viral load suppression among ART-naïve PLHIV in Kenya were associated with significant decrease in D-dimer at 6 months in this large African cohort.

Expansion and scale-up of HIV care and treatment services in four countries over ten years.

BACKGROUND: Scale-up and expansion of antiretroviral therapy (ART) for people living with HIV (PLHIV) have been a global priority for more than 15 years. METHODS: We describe PLHIV at enrollment in care and ART initiation in Ethiopia, Kenya, Mozambique and Tanzania from 2005-2014 and report on enrollment location, CD4 count and loss to follow-up (LTF), death, and combined attrition (LTF and death) pre- and post-ART initiation over time. Pre-ART outcomes were estimated using competing risk and post-ART using Kaplan-Meier estimators; LTF defined as no visit within six months pre-ART and 12 months after ART start. RESULTS: From 2005-2014, 884,328 PLHIV enrolled in care at 350 health facilities, median age was 32.0 years (interquartile range [IQR] 26.0-42.0), and majority were female (66.5%). The proportion of PLHIV enrolled at primary and rural facilities increased from 12.9% and 15.3% in 2005-2006 to 43.5% and 41.7% in 2013-2014 (p<0.0001). Median CD4+ cell count at enrollment increased from 171 cell/mm3 in 2005-2006 (IQR 71-339) to 289 cell/mm3 in 2013-2014 (IQR 133-485) (p<0.0001). A total of 460,758 (57.4%) PLHIV initiated treatment. Cumulative risk of LTF for PLHIV prior to ART initiation 12 months after enrollment was 33.5% (95%CI 33.36-33.58) and 21.98% (95%CI 21.9-22.1) after ART initiation. Pregnant women and the youngest PLHIV group had the highest attrition after ART initiation, at 24 months 40.8% (95%CI 40.1-41.6) of pregnant women and 47.4% (95%CI 46.4-48.4) of PLHIV 15-19 years were not retained. Attrition at 12 months after enrollment among PLHIV regardless of ART status was 38.5% (95%CI 38.4-38.6). CONCLUSION: Over 10 years of HIV scale-up in four sub-Saharan African countries, close to a million PLHIV were enrolled in care increasingly at rural and primary facilities with increasing CD4 count. Loss to follow-up from HIV care remains alarmingly high, particularly among pregnant women and younger PLHIV.

Effectiveness of a Lay Counselor-Led Combination Intervention for Retention of Mothers and Infants in HIV Care: A Randomized Trial in Kenya.

BACKGROUND: Retention of mothers and infants across the prevention of mother-to-child HIV transmission (PMTCT) continuum remains challenging. We assessed the effectiveness of a lay worker administered combination intervention compared with the standard of care (SOC) on mother-infant attrition. METHODS: HIV-positive pregnant women starting antenatal care at 10 facilities in western Kenya were randomized using simple randomization to receive individualized health education, retention/adherence support, appointment reminders, and missed visit tracking vs. routine care per guidelines. The primary endpoint was attrition of mother-infant pairs at 6 months postpartum. Attrition was defined as the proportion of mother-infant pairs not retained in the clinic at 6 months postpartum because of mother or infant death or lost to follow-up. Intent-to-treat analysis was used to assess the difference in attrition. This trial is registered with ClinicalTrials.gov; NCT01962220. RESULTS: From September 2013 to June 2014, 361 HIV-positive pregnant women were screened, and 340 were randomized to the intervention (n = 170) or SOC (n = 170). Median age at enrollment was 26 years (interquartile range 22-30); median gestational age was 24 weeks (interquartile range 17-28). Overall attrition of mother-infant pairs was 23.5% at 6 months postpartum. Attrition was significantly lower in the intervention arm compared with SOC (18.8% vs. 28.2%, relative risk (RR) = 0.67, 95% confidence interval: 0.45 to 0.99, P = 0.04). Overall, the proportion of mothers who were retained and virally suppressed (<1000 copies/mL) at 6 months postpartum was 54.4%, with no difference between study arms. CONCLUSIONS: Provision of a combination intervention by lay counselors can decrease attrition along the PMTCT cascade in low-resource settings.

Lay health worker experiences administering a multi-level combination intervention to improve PMTCT retention.

BACKGROUND: The recent scale-up of prevention of mother-to-child transmission of HIV (PMTCT) services has rapidly accelerated antiretroviral therapy (ART) uptake among pregnant and postpartum women in sub-Saharan Africa. The Mother and Infant Retention for Health (MIR4Health) study evaluates the impact of a combination intervention administered by trained lay health workers to decrease attrition among HIV-positive women initiating PMTCT services and their infants through 6 months postpartum. METHODS: This was a qualitative study nested within the MIR4Health trial. MIR4Health was conducted at 10 health facilities in Nyanza, Kenya from September 2013 to September 2015. The trial intervention addressed behavioral, social, and structural barriers to PMTCT retention and included: appointment reminders via text and phone calls, follow-up and tracking for missed clinic visits, PMTCT health education at home visits and during clinic visits, and retention and adherence support and counseling. All interventions were administered by lay health workers. We describe results of a nested small qualitative inquiry which conducted two focus groups to assess the experiences and perceptions of lay health workers administering the interventions. Discussions were recorded and simultaneously transcribed and translated into English. Data were analyzed using framework analysis approach. RESULTS: Study findings show lay health workers played a critical role supporting mothers in PMTCT services across a range of behavioral, social, and structural domains, including improved communication and contact, health education, peer support, and patient advocacy and assistance. Findings also identified barriers to the uptake and implementation of the interventions, such as concerns about privacy and stigma, and the limitations of the healthcare system including healthcare worker attitudes. Overall, study findings indicate that lay health workers found the interventions to be feasible, acceptable, and well received by clients. CONCLUSIONS: Lay health workers played a fundamental role in supporting mothers engaged in PMTCT services and provided valuable feedback on the implementation of PMTCT interventions. Future interventions must include strategies to ensure client privacy, decrease stigma within communities, and address the practical limitations of health systems. This study adds important insight to the growing body of research on lay health worker experiences in HIV and PMTCT care. TRIAL REGISTRATION: Clinicaltrials.gov NCT01962220 .

Mother Infant Retention for Health (MIR4Health): Study Design, Adaptations, and Challenges With PMTCT Implementation Science Research.

BACKGROUND: Effective retention of HIV-infected mothers and their infants is fraught with multiple challenges, resulting in loss across the continuum of prevention of mother-to-child HIV transmission (PMTCT) care and missed opportunities to offer life-saving HIV prevention and treatment. METHODS: The Mother Infant Retention for Health study is an individual-randomized study evaluating the effectiveness of active patient follow-up compared with standard of care on the combined outcome of attrition of HIV-infected women and their infants at 6 months postpartum. Lay counselors administered the active patient follow-up package of interventions, including individualized health education, use of flip charts during clinic visits, and at home, phone and short message service appointment reminders, active phone and physical tracking of patients immediately after missed clinic visits, and individualized retention and adherence support. RESULTS: Use of study visits to indicate participant progression along the PMTCT cascade highlights the nature of loss among women and infants in PMTCT care because of issues such as pregnancy complications, infant deaths, and transfer out. Delay in implementation of Option B+, unanticipated slow enrollment, a health-care worker strike, rapid HIV test kit shortages, and changes in national PMTCT guidelines necessitated several modifications to the protocol design and implementation to ensure successful completion of the study. CONCLUSIONS: Flexibility when operationalizing an implementation science study is critical in the context of the shifting landscape in a noncontrolled "real-world" setting. TRIAL REGISTRATION: Clinicaltrials.gov NCT01962220.

Use of a Comprehensive HIV Care Cascade for Evaluating HIV Program Performance: Findings From 4 Sub-Saharan African Countries.

BACKGROUND: The traditional HIV treatment cascade has been noted to have limitations. A proposed comprehensive HIV care cascade that uses cohort methodology offers additional information as it accounts for all patients. Using data from 4 countries, we compare patient outcomes using both approaches. METHODS: Data from 390,603 HIV-infected adults (>15 years) enrolled at 217 facilities in Kenya, Mozambique, Rwanda, and Tanzania from 2005 to 2011 were included. Outcomes of all patients at 3, 6, and 12 months after enrollment were categorized as optimal, suboptimal, or poor. Optimal outcomes included retention in care, antiretroviral therapy (ART) initiation, and documented transfer. Suboptimal outcomes included retention in care without ART initiation among eligible patients or those without eligibility data. Poor outcomes included loss to follow-up and death. RESULTS: The comprehensive HIV care cascade demonstrated that at 3, 6 and 12 months, 58%, 51%, and 49% of patients had optimal outcomes; 22%, 12%, and 7% had suboptimal outcomes, and 20%, 37% and 44% had poor outcomes. Of all patients enrolled in care, 56% were retained in care at 12 months after enrollment. In comparison, the traditional HIV treatment cascade found 89% of patients enrolled in HIV care were assessed for ART eligibility, of whom 48% were determined to be ART-eligible with 70% initiating ART, and 78% of those initiated on ART retained at 12 months. CONCLUSIONS: The comprehensive HIV care cascade follows outcomes of all patients, including pre-ART patients, who enroll in HIV care over time and uses quality of care parameters for categorizing outcomes. The comprehensive HIV care cascade provides complementary information to that of the traditional HIV treatment cascade and is a valuable tool for monitoring HIV program performance.

Characteristics and outcomes of HIV-infected youth and young adolescents enrolled in HIV care in Kenya.

BACKGROUND: The number of youth and adolescents (10-24 years) with HIV infection has increased substantially presenting unique challenges to effective health service delivery. METHODS: We examined routinely collected patient-level data for antiretroviral treatment (ART)-naive HIV-infected patients, aged 10-24 years, enrolled in care during 2006-2011 at 109 ICAP-supported health facilities in three provinces in Kenya. Loss to follow-up (LTF) was defined as having no clinic visit for 12 months prior to ART initiation (pre-ART) and 6 months for ART patients. Competing risk and Kaplan-Meier estimators were used to calculate LTF and death rates. Sub-distributional and Cox proportional-hazards models were used to identify potential predictors of death and LTF. RESULTS: Overall 22 832 patients were enrolled in care at 10-24 years of age, 69.5% were aged 20-24 years, and 82% were female. Median CD4(+) cell count was 332 cells/µl (interquartile range 153-561); 70.8% were WHO stage I/II. Young adolescents (10-14 years) had more advanced WHO stage and lower median CD4(+) cell count compared to youth (15-24 years) at enrollment (284 vs. 340 cells/µl; P < 0.0001). Cumulative incidence of LTF and death at 24 months for pre-ART patients was 46.1% [95% confidence interval (CI) 45.4-46.8%) and 2.1% (95% CI 1.9-2.3%), respectively. For those on ART, 32.2% (95% CI 31.1-33.3%) were LTF and 3.9% (95% CI 1.7-2.3%) died within 24 months. LTF among pre-ART and ART patients was twice as high among youth compared to young adolescents. CONCLUSION: LTF of young people with HIV in this Kenyan cohort was high and notably greater among youth compared to young adolescents. Novel strategies targeting these populations are urgently needed to improve retention.

Perceptions of food-insecure HIV-positive adults participating in a food supplementation program in central Kenya.

Malnutrition coexists with HIV in sub-Saharan Africa. Food supplementation is recommended for food-insecure, HIV-positive individuals. This study was part of a larger six-month food supplementation program for adults initiating antiretroviral therapy (ART) in central Kenya. We conducted 10 focus group interviews with program participants to examine the perceptions of participants regarding the food supplementation program. Focus group transcripts were analyzed for themes and six were identified. These were perception of food insecurity and the health of the participants, the benefits of participating, use of the food, coping strategies after the program ended, suggestions for improving the program, and sustainability of the benefits. Participants perceived that the food improved their health and ART adherence, and reduced stigma. The improvements were not always sustained. Sharing with people beyond the immediate family was very common, depleting the food available to the participants. Interventions with sustainable effects for food-insecure, HIV-positive individuals and their families are needed.

Advanced disease at enrollment in HIV care in four sub-Saharan African countries: change from 2006 to 2011 and multilevel predictors in 2011.

OBJECTIVES: To examine changes between 2006 and 2011 in the proportion of HIV-positive patients newly enrolled in HIV care with advanced disease and the median CD4 cell count at enrollment; and identify patient, facility, and contextual-level factors associated with late enrollment in care in 2011. DESIGN: Cross-sectional over time. METHODS: For time-trends analyses, routinely collected patient-level data (307 110 adults newly enrolled in 138 HIV clinical care facilities) in Kenya, Mozambique, Rwanda and Tanzania; and for analyses of correlates, patient-level data (46 201 in 195 facilities), and facility and population-level survey data were used. Late enrollment was defined as CD4 cell count 350 cells/µl or less and/or WHO clinical stage 3/4. RESULTS: Late enrollment declined from 69.9 to 57.2% (P < 0.0001); median CD4 cell count increased from 242 to 292 cells/µl (Ptrend < 0.0001). In 2011, risk of late enrollment was significantly higher for men and nonpregnant women vs. pregnant women; patients aged above 25 vs. 15-25 years; nonmarried vs. married; and those entering from sites other than prevention of mother-to-child transmission. More extensive HIV testing coverage in the region of a facility was significantly associated with lower risk of late enrollment. CONCLUSIONS: Despite improvement, in 2011, 57% of patients entered HIV care who were already antiretroviral therapy-eligible. The lower risk of late enrollment among those referred from prevention of mother-to-child transmission and in regions where HIV testing coverage was higher suggests that innovative approaches to rapidly increase testing uptake among people living with HIV prior to the development of symptoms have the potential to reduce late enrollment in care.

Decentralization of HIV care and treatment services in Central Province, Kenya.

BACKGROUND: Since 2006, the government of Kenya began decentralizing HIV care from secondary health facilities (SHF) to an expanded network, including primary health facilities (PHF). We evaluated the impact of this strategy on enrollment, care, and outcomes among adult patients in Central Province, Kenya, from 2006 to 2010. METHODS: We analyzed electronic patient-level data for 26,690 patients at 15 SHF and 22 PHF. Enrollment, patient, and facility characteristics and patterns in CD4 testing, World Health Organization staging, and antiretroviral treatment (ART) initiation were compared between SHF and PHF. Survival analysis was used to estimate cumulative death and loss to follow-up (LTF) rates in PHF and SHF. Multivariate competing risks regression and Cox proportional hazards models were constructed to identify correlates of LTF and death. RESULTS: Enrollment in PHF increased mainly between 2007 and 2009, representing 5% and 25% of all new enrollments, respectively. CD4 test provision and World Health Organization staging, time to ART initiation, and CD4 count at ART initiation were for the most part similar between PHF and SHF. In multivariate analyses, pre-ART patients enrolled in PHF had a lower risk of LTF than those enrolled in SHF (SHR = 0.77, 95% confidence interval: 0.61 to 0.96). No differences in risk of death among pre-ART patients or in LTF or death among ART patients were observed. CONCLUSIONS: Enrollment at PHF increased substantially during the period; death rates were comparable between PHF and SHF, whereas LTF among pre-ART patients was lower at PHF. This suggests that decentralization can be a successful strategy for expanding HIV care.

Rationale and design of a study using a standardized locally procured macronutrient supplement as adjunctive therapy to HIV treatment in Kenya.

Poor nutritional status at initiation of antiretroviral therapy (ART) is predictive of mortality. Decreased dietary intake is a major determinant of weight loss in HIV. Despite a biological rationale to treat undernutrition in adults receiving ART, few studies have provided data on feasibility, safety, effectiveness, and sustainability of specific macronutrient supplements with HIV treatment in adults, especially supplements such as a food basket, a supplement approach seldom evaluated in spite of its wide use. We present the rationale and design for a study of a locally procured macronutrient supplement given to HIV-infected patients initiating ART with a body mass index (BMI) ≤20.0 kg/m(2). The objective was to determine feasibility of procurement, distribution, safety and to obtain preliminary effectiveness data for a locally procured supplement. The design was a comparative study for 200 adult participants at two Kenya government-supported clinics. The primary outcome was BMI at 24 weeks. Supplement duration was 24 weeks, total follow-up was 48 weeks, and the study included a comparison site. Novel aspects of this study include use of a standardized macronutrient supplement to protect the participant against household food sharing, and a complementary micronutrient supplement. Comprehensive data collected included dietary intake, HIV-related quality-of-life, food security, neuropsychiatric assessments, laboratory studies, and household geomapping. Assessments were made at baseline, at 24 weeks, and at 48 weeks post-ART initiation. Challenges included establishing a partnership with local millers, distribution from the HIV clinic, food safety, and tracking of participants. These findings will help inform nutrition support programming in Kenya and similar settings, and provide needed data regarding use of macronutrient supplements as an adjunctive intervention with ART.

Randomised controlled trial on whether advance knowledge of prostate-specific antigen testing improves participant reporting of unprotected sex.

OBJECTIVES: To determine whether the process of informing research participants that they would be tested for the presence of a biological marker of semen exposure would reduce bias in their reports of unprotected sex. METHODS: A randomised trial of 210 female sex workers from Mombasa, Kenya, was conducted, where half the group had advance knowledge (via the request for informed consent) that they would be tested for prostate-specific antigen (PSA) in their vaginal fluid before they reported on sex and condom use for the past 48 h. The other half were invited to participate (via additional informed consent) in the test for PSA after they had already consented to be questioned and reported on these sexual behaviours. A trained nurse instructed participants to self-swab to collect vaginal fluid specimens, which were tested for PSA using ELISA. RESULTS: Reporting of unprotected sex did not differ between those with advance knowledge of the test for PSA and those without this knowledge (14.3% v 11.4%, respectively; p = 0.27). Surprisingly, more women with advance knowledge (15.8%) had discrepant self reports and PSA results than women without advance knowledge (9.1%); however, the difference was not statistically significant (OR 1.9; 95% CI 0.8 to 4.5). CONCLUSIONS: Knowing that one's answers to a questionnaire could be verified with a biological marker of semen exposure did not make respondents more likely to report unprotected sex.

Low use of skilled attendants' delivery services in rural Kenya.

The aim of the study was to estimate the use of skilled attendants' delivery services among users of antenatal care and the coverage of skilled attendants' delivery services in the general population in Kikoneni location, Kenya. Data collected from the registers at the Kikoneni Health Centre (KHC) from March 2001 through March 2003 were retrospectively reviewed. Antenatal care attendance, deliveries by skilled attendants, and the percentage of antenatal care attendees who delivered in a healthcare facility were assessed. Deliveries at the KHC were compared with expected births in the population to estimate the coverage of deliveries assisted by skilled attendants in the community. Of 994 women who attended the antenatal care clinic, 74 (7.4%) presented for delivery services. 5.4% of expected births in the population occurred in health facilities. The coverage of deliveries assisted by skilled attendants was far below the national and international goals. The use of institutional delivery services was very low even among antenatal care attendees. Targeted programmatic efforts are necessary to increase skilled attendant-assisted births, with the ultimate goal of reducing maternal mortality.