Antiretroviral Therapy In Kenya Research Articles

Retrospective longitudinal analysis of low-level viremia among HIV-1 infected adults on antiretroviral therapy in Kenya

HIV low-level viremia (LLV) (51-999 copies/mL) can progress to treatment failure and increase potential for drug resistance. We analyzed retrospective longitudinal data from people living with HIV (PLHIV) on antiretroviral therapy (ART) in Kenya to understand LLV prevalence and virologic outcomes. We calculated rates of virologic suppression (≤50 copies/mL), LLV (51-999 copies/mL), virologic non-suppression (≥1000 copies/mL), and virologic failure (≥2 consecutive virologic non-suppression results) among PLHIV aged 15 years and older who received at least 24 weeks of ART during 2015-2021. We analyzed risk for virologic non-suppression and virologic failure using time-dependent models (each viral load (VL) <1000 copies/mL used to predict the next VL). Of 793,902 patients with at least one VL, 18.5% had LLV (51-199 cp/mL 11.1%; 200-399 cp/mL 4.0%; and 400-999 cp/mL 3.4%) and 9.2% had virologic non-suppression at initial result. Among all VLs performed, 26.4% were LLV. Among patients with initial LLV, 13.3% and 2.4% progressed to virologic non-suppression and virologic failure, respectively. Compared to virologic suppression (≤50 copies/mL), LLV was associated with increased risk of virologic non-suppression (adjusted relative risk [aRR] 2.43) and virologic failure (aRR 3.86). Risk of virologic failure increased with LLV range (aRR 2.17 with 51-199 copies/mL, aRR 3.98 with 200-399 copies/mL and aRR 7.99 with 400-999 copies/mL). Compared to patients who never received dolutegravir (DTG), patients who initiated DTG had lower risk of virologic non-suppression (aRR 0.60) and virologic failure (aRR 0.51); similarly, patients who transitioned to DTG had lower risk of virologic non-suppression (aRR 0.58) and virologic failure (aRR 0.35) for the same LLV range. Approximately a quarter of patients experienced LLV and had increased risk of virologic non-suppression and failure. Lowering the threshold to define virologic suppression from <1000 to <50 copies/mL to allow for earlier interventions along with universal uptake of DTG may improve individual and program outcomes and progress towards achieving HIV epidemic control. No specific funding was received for the analysis. HIV program support was provided by the President's Emergency Plan for AIDS Relief (PEPFAR) through the United States Centers for Disease Control and Prevention (CDC).

Prevalence and predictors of virologic failure among HIV patients on antiretroviral therapy in Makueni County: a cross-sectional study

Background: The growing number of people on antiretroviral therapy in Kenya has led to a decrease in HIV morbidity and mortality. However, virologic failure (VF) threatens to reverse these gains. In Makueni County, existing data indicate challenges in achieving viral load (VL) suppression among persons living with HIV (PLHIV). Few studies have been carried out investigating VF in the region despite its high incidence of HIV infections. Methods: An analytical cross-sectional study was conducted among PLHIV in Makueni County to investigate the determinants and estimate the prevalence of VF. The prevalence of VF and its associated 95% exact binomial confidence interval was estimated, and a mixed-effects logistic regression model used to evaluate the relationship between the predictors and VF. Results: The estimated period prevalence of VF between October 2018 and June 2019 was 13.2% (95% CI: 12.7%–13.8%). Being 15 years or older (aOR=0.53; 95% CI: 0.44 – 0.645) and having blood samples tested for reasons other than baseline VL measurement was associated with lower odds of VF: breastfeeding mothers (aOR=0.1; 95% CI: 0.01 – 0.97); clinical failure (aOR=0.08; 95% CI: 0.01 – 0.44); confirmation of VF (aOR=0.2; 95% CI: 0.07 – 0.62); no VL data (aOR=0.06; 95% CI: 0.01 – 0.31); routine VL (aOR=0.04; 95% CI: 0.01 – 0.12); drug substitution (aOR=0.03; 95% CI: 0.01 – 0.08). Taking ABC-based, AZT-based, or other non-TDF-Based regimens increased the odds of VF (aOR=1.61; 95% CI: 1.34 – 1.94), (aOR=1.75; 95% CI: 1.52 - 2.01), and (aOR=1.55; 95% CI: 0.99 - 2.44) respectively. Conclusion: This study showed that over 13% of HIV patients on ART in Makueni County had VF between October 2018 and June 2019. The significant risk factors associated with VF were found to be age lower than 15 years, taking a non-TDF-based ART regimen, and blood sampling for baseline VL measurements.

Treatment factors associated with viral suppression among adolescents on antiretroviral therapy in Kenya

Background: There are approximately 99,159 adolescents living with human immunodeficiency virus in Kenya, with a viral suppression rate of 67%, according to the Joint United Nations Program on HIV/AIDS in 2021 [1] . There are limited studies in Kenya on factors associated with viral load suppression among adolescents. The objectives of this study were to determine the treatment factors associated with viral suppression among adolescents on antiretroviral therapy. Methods: A retrospective cross-sectional analysis of 38,503 HIV-infected adolescents receiving antiretroviral therapy for at least 6 months with a documented viral load result. The data was from routinely collected HIV program data in Kenya that is submitted from comprehensive care centers with electronic medical records to the National Aids and STI Control Program (NASCOP) for the period of January 2018–December 2022. Results: The study population was 38503 HIV-infected adolescents (10–19 years) on antiretroviral therapy. The viral suppression was at 81.2%., higher than the 2021 UNAIDS estimate of 67%. low detectable levels were 88%, low level viremia was 12%, high-risk LLV was 38%, and suspected treatment failure as 62%. Virological suppression with integrase strand transfer inhibitors based regimens – Abacavir and Tenofovir was 81.6% and 86.4%, respectively. The suppression with protease inhibitors based regimens was 70% (highest) and 56.4% (Lowest) Conclusion: The viral suppression among adolescents on antiretroviral therapy was 81.2% lower than the UNAIDS 95/95/95 global target but higher than the 2021 UNAIDS estimate of 67%. There is a need to interrogate the viral suppression in adolescents on protease inhibitors.

Contraception use and HIV outcomes among women initiating dolutegravir-containing antiretroviral therapy in Kenya: a retrospective cohort study.

The rollout of dolutegravir (DTG) in low- and middle-income countries was disrupted by a potential association reported with periconceptional DTG exposure among women living with HIV (WLHIV) and infant neural tube defects. This prompted countries to issue interim guidance limiting DTG use among women of reproductive potential to those on effective contraception. Data to understand the potential impact of such guidance on WLHIV are limited. We conducted a retrospective cohort analysis of WLHIV 15-49 years initiating DTG-containing antiretroviral treatment (ART) in Kenya from 2017 to 2020. We determined baseline effective (oral, injectable or lactational amenorrhea) and very effective (implant, intrauterine device or female sterilization) contraception use among women who initiated DTG before (Group 1) or during (Group 2) the interim guideline period. We defined incident contraception use in each group as the number of contraceptive methods initiated ≤180 days post-guideline (Group 1) or post-DTG initiation (Group 2). We determined the proportions of all women who switched from DTG- to non-nucleoside reverse transcriptase inhibitor (NNRTI)- (efavirenz or nevirapine) containing ART ≤12 months post-DTG initiation, compared their viral suppression (<1000 copies/ml) and conducted multivariable logistic regression to determine factors associated with switching from DTG to NNRTI-containing ART. Among 5155 WLHIV in the analysis (median age 43 years), 89% initiated DTG after transitioning from an NNRTI. Baseline effective and very effective contraception use, respectively, by the group were: Group 1 (12% and 13%) and Group 2 (41% and 35%). Incident contraception use in each group was <5%. Overall, 498 (10%) women switched from DTG to an NNRTI. Viral suppression among those remaining on DTG versus switched to NNRTI was 95% and 96%, respectively (p = 0.63). In multivariable analysis, incident effective and very effective contraception use was not associated with switching. Baseline, but not incident, effective contraception use was higher during the interim guideline period compared to before it, suggesting women already using effective contraception were preferentially selected to initiate DTG after the guideline was released. These findings reveal challenges in the implementation of policy which ties antiretroviral access to contraceptive use. Future guidance should capture nuances of contraception decision-making and support women's agency to make informed decisions.

The Utility of Health and Wealth for HIV Patients on Antiretroviral Therapy in Kenya

Aims/ Objectives: To determine the appropriate utility function that models the trade o between health and wealth for HIV/AIDS patients on Antiretroviral Therapy in Kenya.&#x0D; Study Design: Retrospective study.&#x0D; Place and Duration of Study: Jomo Kenyatta University of Agriculture and Technology, between January 2019-April 2022.&#x0D; Methodology: The study involved a retrospective study of 2800 patients on Antiretroviral Therapy in Kenya from the period of 2005-2017. All the records are in terms of random patient id and in no way is the privacy and anonymity of patients is compromised. The inclusion criteria is patients who had complete information on the covariates used in the model over the follow up period. The logarithmic utility function, the negative exponential utility function and the power utility function are compared using the Akaike Information Criterion to determine which one best fits the empirical data to model the health and wealth trade off of patients on Antiretroviral Therapy in Kenya.&#x0D; Results: Women constituted 66% of the sample. Only patients over the age of 18 years were included in the study. The mean age was 40.3. The health related quality of life values were calculated for each patient on Antiretroviral Therapy using the proxy utility function approach. The costs associated with receiving Antiretroviral Therapy treatment were obtained from simulating from a gamma distribution with ranges from existing published literature. The logarithmic utility function had the least AKaike Information Criterion.&#x0D; Conclusion: The marginal utility of health increases with wealth for People living with HIV and the logarithmic utility function is suitable for modelling the shape of preferences for the trade off between health and wealth for HIV patients on Antiretroviral Therapy.

Adolescent and young adult preferences for financial incentives to support adherence to antiretroviral therapy in Kenya: a mixed methods study.

IntroductionTo develop a patient‐centred financial incentive delivery strategy to improve antiretroviral treatment adherence in adolescents and young adults (AYA) living with HIV in Kisumu, Kenya, we conducted a mixed methods study exploring preferences.MethodsA discrete choice experiment (DCE) and focus group discussion (FGD) were conducted simultaneously to identify preferences for five incentive delivery strategy features: value, eligibility, recipient, format and disbursement frequency. We used consecutive sampling to recruit AYA (14–24 years) living with HIV attending three health facilities in Kisumu, Kenya. We calculated mean preferences, willingness to trade, latent class membership and predictors of latent class membership. The FGD explored preferred incentive features, and, after deductive and inductive coding, qualitative findings were triangulated with DCE results.ResultsTwo hundred and seven AYA living with HIV (46% 14–17 years, 54% 18–24 years; 33% male sex, 89% viral load <50 copies/ml) were recruited to the study (28 October–16 November 2020). Two distinct preference phenotypes emerged from the DCE analysis (N = 199), 44.8% of the population fell into an “immediate reward” group, who wanted higher value cash or mobile money distributed at each clinic visit, and 55.2% fell into a “moderate spender” group, who were willing to accept lower value incentives in the form of cash or shopping vouchers, and accrued payments. The immediate reward group were willing to trade up to 200 Kenyan Shillings (KSH)—approximately 2 US dollars (USD)—of their 500 KSH (∼5 USD) incentive to get monthly as opposed to accrued yearly payments. The strongest predictor of latent class membership was age (RR 1.45; 95% CI: 1.08–1.95; p = 0.006). Qualitative data highlighted the unique needs of those attending boarding school and confirmed an overwhelming preference for cash incentives which appeared to provide the greatest versatility for use.ConclusionsProviding small financial incentives as cash was well‐aligned with AYA preferences in this setting. AYA should additionally be offered a choice of other incentive delivery features (such as mobile money, recipient and disbursement frequency) to optimally align with the specific needs of their age group and life stage.

Attitudes towards and experiences with economic incentives for engagement in HIV care and treatment: Qualitative insights from a randomized trial in Kenya.

Growing literature has shown heterogenous effects of conditional cash incentives (CCIs) on HIV care retention. The field lacks insights into reasons why incentives impact various patients in different ways-differences that may be due to variations in psychological and social mechanisms of effect. A deeper understanding of patients' perceptions and experiences of CCIs for retention may help to clarify these mechanisms. We conducted a qualitative study embedded in the ADAPT-R trial (NCT#02338739), a sequential multiple assignment randomized trial (SMART) that evaluated economic incentives to support retention in HIV care among persons living with HIV (PLHIV) initiating antiretroviral therapy in Kenya. Participants who attended their scheduled clinic visits received an incentive of approximately $4 each visit. Interviews were conducted between July 2016 and June 2017 with 39 participants to explore attitudes and experiences with economic incentives conditional on care engagement. Analyses revealed that incentives helped PLHIV prioritize care-seeking by alleviating transport barriers and food insecurity: "I decided to forgo [work] and attend clinic […] the voucher relieved me". Patients who borrowed money for care-seeking reported feeling relieved from the burden of indebtedness to others: "I borrow with confidence that I will pay after my appointment." Incentives fostered their autonomy, and enabled them to support others: "I used the money to buy some clothes and Pampers for the children." Participants who were intrinsically motivated to engage in care ("my life depends on the drugs, not the incentive"), and those who mistrusted researchers, reported being less prompted by the incentive itself. For patients not already prioritizing care-seeking, incentives facilitated care engagement through alleviating transport costs, indebtedness and food insecurity, and also supported social role fulfillment. Conditional cash incentives may be an important cue to action to improve progression through the HIV treatment cascade, and contribute to better care retention.

A Comparative Study on Effect of Caregivers Training on Health Outcomes of HIV Infected Children on Antiretroviral Therapy in Kenya

The purpose of this cohort study was to assess the effect of caregiver training on health outcomes of HIV-infected children aged 1-14 years on antiretroviral therapy in South Rift Valley, Kenya. Three hundred and twenty children of trained caregivers and 778 children of non-trained caregivers were targeted from four hospitals. Population proportionate to size sampling technique was used to calculate number of children enrolled. Children medical chart for trained and non-trained caregivers were stratified as per year of training, 2014, 2015, 2016 and randomly selected numbers matched with corresponding medical record. Data was collected through review of medical records, questionnaires and caregivers interview. There was significant association between caregiver training and adherence (Fisher's Exact Test X 2 =22.740, p = .001). Children of trained caregivers had significant reductions in viral load (Kruskal Wallis X 2 =7.124, p = .028); significant difference in viral loads was also observed between trained and non-trained caregivers (Mann-Whitney U=19846, p =.012), significant association in episodes of opportunistic infections before, after and among non-trained caregivers (Fisher's Exact Test X 2 =76.768, p = .001). Nutritional status of children was not associated with caregivers training (Pearson Chi-square X 2 = 11.616, p =.072). Most caregivers perceived training to be useful. The study found that, training enables caregivers to improve adherence levels of HIV infected children on antiretroviral therapy. Even though there are HIV information in public domain, the study found, if this information is provided in a structured manner, enables suppression of viral loads of HIV infected children. Training caregivers significantly reduces frequency of opportunistic infections among HIV infected children on antiretroviral therapy. Providing information on nutrition to caregivers does not affect nutritional status of HIV infected children. Training caregivers on HIV information improves health outcomes of HIV infected children thus study provide evidence–based decision making in rolling out caregivers training nationally. Keywords: HIV, Caregivers, Training, Children, Adherence, DOI: 10.7176/JHMN/76-05 Publication date: June 30th 2020

Ten-year survival with analysis of gender difference, risk factors, and causes of death during 13 years of public antiretroviral therapy in rural Kenya.

Evidence for why antiretroviral therapy (ART) outcomes differ by gender in developing countries has been inconclusive. In this first study to assess 10-year survival on ART in Kenya, our objective was to compare gender differences in survival for those who began ART as adults and as children. Kakamega County Referral Hospital (KCRH) is a tertiary rural hospital that has provided public ART to Kenyans since 2004. All patients enrolled in ART at KCRH who died between July 2004 and March 2017 and a sample of living patients were included in a survival analysis that bootstrapped sampled data. Case-cohort regressions identified adjusted hazard ratios. In total, 1360 patients were included in the study. Ten-year survival was 77% (95% confidence band [CB] 73-81%), significantly different for men (65%; 95% CB: 45-74%) and women (83%; 95% CB: 78-86%) who began therapy as adults. Ten-year survival was intermediate with no significant gender difference (76%; 95% CB: 69-81%) for patients who began therapy as children. Hazard of death was increased for men (hazard ratio [HR] 1.56; 95% confidence interval [CI] 1.13-2.17), infants (HR 2.87; 95% CI 1.44-5.74), patients with consistently poor clinic attendance (HR 3.94; 95% CI 3.19-4.86), and divorced patients (HR 2.25; 95% CI 1.19-4.25). Tuberculosis, diarrheal illnesses, human immunodeficiency virus (HIV) wasting syndrome, and malaria were leading causes of death. Survival was significantly lower for men than for women in all time periods, but only for patients who began therapy as adults, indicating against biological etiologies for the gender mortality difference.

Validation of a self-report adherence measurement tool among a multinational cohort of children living with HIV in Kenya, South Africa and Thailand.

IntroductionThere are few data on adherence and low‐cost measurement tools for children living with HIV. We collected prospective data on adherence to antiretroviral therapy (ART) among a multinational cohort of children to evaluate an adherence questionnaire.MethodsWe enrolled 319 children ages 0 to 16 years on ART in Kenya (n = 110), South Africa (n = 109) or Thailand (n = 100). Children were followed up for six months of adherence monitoring between March 2015 and August 2016 using Medication Event Monitoring Systems (MEMS ®) with at least one viral load measure. At month 3 and 6, children or their caregivers were administered a 10‐item adherence questionnaire. Repeated measures analyses were used to compare responses on questionnaire items to external adherence criteria: MEMS ® dichotomized adherence (≥90% of doses taken vs. <90%), 48‐hour MEMS ® treatment interruptions and viral suppression (<1000 copies/mL). Items associated with outcomes (p < 0.10) were coefficient‐weighted to calculate a total adherence score, which was tested in multivariate regression against MEMS ® and viral suppression outcomes. Odds ratios (OR) and 95% confidence intervals (95% CI) were calculated.ResultsMean child age was 11 years and 54% were female. Children from Thailand (median age 14 years) were significantly older compared to Kenya (10 years) and South Africa (10 years). Prevalence of viral suppression was 97% in Thailand, 81% in South Africa and 69% in Kenya, while the prevalence of MEMS ® adherence ≥90% was 57% in Thailand, 58% in South Africa and 40% in Kenya. Across sites, child‐reported adherence using the questionnaire was significantly associated with dichotomized MEMS ® adherence (OR 1.8, 95% CI 1.4 to 2.4), 48‐hour treatment interruptions (OR 0.41, 95% CI 0.3 to 0.6), and viral suppression (OR 3.4, 95% CI 1.7 to 6.7). We did find, however, that different cut‐points for the adherence score may be context‐specific. For example, MEMS ® non‐adherent children in Kenya had a lower adherence score (0.98) compared to South Africa (1.77) or Thailand (1.58).ConclusionsWe found suboptimal adherence to ART was common by multiple measures in this multi‐country cohort of children. The short‐form questionnaire demonstrated reasonable validity to screen for non‐adherence in these diverse settings.

‘I saw it as a second chance’: A qualitative exploration of experiences of treatment failure and regimen change among people living with HIV on second- and third-line antiretroviral therapy in Kenya, Malawi and Mozambique

ABSTRACTIncreasing numbers of people living with HIV (PLHIV) in sub-Saharan Africa are experiencing failure of first-line antiretroviral therapy and transitioning onto second-line regimens. However, there is a dearth of research on their treatment experiences. We conducted in-depth interviews with 43 PLHIV on second- or third-line antiretroviral therapy and 15 HIV health workers in Kenya, Malawi and Mozambique to explore patients’ and health workers’ perspectives on these transitions. Interviews were audio-recorded, transcribed and translated into English. Data were coded inductively and analysed thematically. In all settings, experiences of treatment failure and associated episodes of ill-health disrupted daily social and economic activities, and recalled earlier fears of dying from HIV. Transitioning onto more effective regimens often represented a second (or third) chance to (re-)engage with HIV care, with patients prioritising their health over other aspects of their lives. However, many patients struggled to maintain these transformations, particularly when faced with persistent social challenges to pill-taking, alongside the burden of more complex regimens and an inability to mobilise sufficient resources to accommodate change. Efforts to identify treatment failure and support regimen change must account for these patients’ unique illness and treatment histories, and interventions should incorporate tailored counselling and social and economic support.

Comparison of Zidovudine and Tenofovir Based Regimens With Regard to Health-Related Quality of Life and Prevalence of Symptoms in HIV Patients in a Kenyan Referral Hospital

Aim: Zidovudine and tenofovir form the backbone of antiretroviral therapy in Kenya. However, their side-effects may affect the quality of life (QoL) of patients. The aim was to compare the health-related quality of life (HRQoL) of adult patients on tenofovir versus zidovudine based regimens in a referral hospital in Kenya to provide future guidance.Methods: A comparative cross sectional study among 501 adult out-patients on either tenofovir or zidovudine was undertaken in Kenyatta National Hospital between 2015 and 2016. The Medical Outcome Study HIV Health Survey (MOS-HIV) was administered along with other key aspects of treatment. Linear regression analysis was performed to identify determinants of HRQoL.Results: Patients on zidovudine had a higher Physical Health Summary Score (PHSS) and Mental Health Summary Score (MHSS) compared to those on tenofovir. The presence of any symptom of the disease and a stated inability to cope were negatively associated with PHSS, whilst having a regular source of income improved PHSS. Being on tenofovir, symptom of illness [β = -1.24; 95% CI (-2.253, -0.226)], absence of pain [β=0.413; 95% CI (0.152, 0.674)] and patient stated inability to cope with HIV [β = -1.029; 95% CI (-1.441, -0.617)] affected the MHSS. Patients on tenofovir and second line regimens had more signs and symptoms of illness.Conclusion: Participants on zidovudine based regimens showed a better performance across all aspects of HRQoL. These are considerations for the future.

Validation of a Short Adherence Questionnaire for Children Living with HIV on Antiretroviral Therapy in Kenya

Background:There are few validated tools to measure adherence for children living with HIV. We identified questionnaire items for caregivers of Kenyan children aged <15 years living with HIV.Methods:Caregiver–child dyads were followed for 6 months. At monthly visits, the child’s HIV provider administered a 10-item questionnaire to the caregiver. Children were given electronic dose monitors (Medication Event Monitoring Systems [MEMS]). Correlation between questionnaire items and dichotomized MEMS adherence (≥90% doses taken versus <90%) was investigated using logistic regression models.Results:In 95 caregiver–child dyads, mean age of children (40% female) was 8.3 years. Items associated with higher odds of MEMS adherence in multivariable analysis included the father giving the child medication, being enrolled in a nutrition program, and the caregiver reporting no difficulties giving the child medication.Conclusion:Providers typically ask about missed doses, but asking about caregiver responsibilities and difficulties in giving the child medication may better detect suboptimal adherence.

Sustained Responses to Measles Revaccination at 24 Months in HIV-infected Children on Antiretroviral Therapy in Kenya.

There are limited data on whether HIV-infected children in resource-limited countries who are receiving antiretroviral therapy (ART) are able to produce sustained, protective levels of measles antibody after multiple measles vaccinations. We administered an additional measles vaccine to HIV-infected children 15 months to 12 years of age receiving ART in Nairobi, Kenya. Measles antibody concentrations were determined by enzyme-linked immunosorbent assay at enrollment, 1 month, 12 months and 24 months post revaccination. At enrollment, 125 (54%) of 232 study participants had protective concentrations of measles antibody. Measles seropositivity increased to 98% of all children at 1 month post revaccination but decreased to 71% at 12 months and 60% at 24 months post revaccination. Measles seroconversion and sustained measles seropositivity among those who were measles seronegative at enrollment was 25% at 24 months post revaccination. In this group, 39% of children with <50 copies/mL plasma HIV RNA measles seroconverted compared to 4% of children with plasma HIV RNA ≥1000 copies/mL (P = 0.018). Measles revaccination can result in a sustained antibody response in a subset of HIV-infected children receiving ART, especially among those with HIV suppression.

Positive Predictive Value of the WHO Clinical and Immunologic Criteria to Predict Viral Load Failure among Adults on First, or Second-Line Antiretroviral Therapy in Kenya.

Routine HIV viral load (VL) monitoring is the standard of care for persons receiving antiretroviral therapy (ART) in developed countries. Although the World Health Organization recommends annual VL monitoring of patients on ART, recognizing difficulties in conducting routine VL testing, the WHO continues to recommend targeted VL testing to confirm treatment failure for persons who meet selected immunologic and clinical criteria. Studies have measured positive predictive value (PPV), negative predictive value, sensitivity and specificity of these criteria among patients receiving first-line ART but not specifically among those on second-line or subsequent regimens. Between 2008 and 2011, adult ART patients in Nyanza, Kenya who met national clinical or immunologic criteria for treatment failure received targeted VL testing. We calculated PPV and 95% confidence intervals (CI) of these criteria to detect virologic treatment failure among patients receiving a) first-line ART, b) second/subsequent ART, and c) any regimen. Of 12,134 patient specimens tested, 2,874 (23.7%) were virologically confirmed as treatment failures. The PPV for 2,834 first-line ART patients who met either the clinical or immunologic criteria for treatment failure was 34.4% (95% CI 33.2–35.7), 33.1% (95% CI 24.7–42.3) for the 40 patients on second-line/subsequent regimens, and 33.4% (95% CI 33.1–35.6) for any ART. PPV, regardless of criteria, for first-line ART patients was lowest among patients over 44 years old and highest for patients aged 15 to 34 years. PPV of immunological and clinical criteria for correctly identifying treatment failure was similarly low for adult patients receiving either first-line or second-line/subsequent ART regimens. Our data confirm the inadequacy of clinical and immunologic criteria to correctly identify treatment failure and support the implementation of routine VL testing.

Time Preferences Predict Mortality among HIV-Infected Adults Receiving Antiretroviral Therapy in Kenya.

BackgroundIdentifying characteristics of HIV-infected adults likely to have poor treatment outcomes can be useful for targeting interventions efficiently. Research in economics and psychology suggests that individuals’ intertemporal time preferences, which indicate the extent to which they trade-off immediate vs. future cost and benefits, can influence various health behaviors. While there is empirical support for the association between time preferences and various non-HIV health behaviors and outcomes, the extent to which time preferences predict outcomes of those receiving antiretroviral therapy (ART) has not been examined previously.MethodsHIV-infected adults initiating ART were enrolled at a health facility in Kenya. Participants’ time preferences were measured at enrollment and used to classify them as having either a low or high discount rate for future benefits. At 48 weeks, we assessed mortality and ART adherence, as measured by Medication Event Monitoring System (MEMS). Logistic regression models adjusting for socio-economic characteristics and risk factors were used to determine the association between time preferences and mortality as well as MEMS adherence ≥90%.ResultsOverall, 44% (96/220) of participants were classified as having high discount rates. Participants with high discount rates had significantly higher 48-week mortality than participants with low discount rates (9.3% vs. 3.1%; adjusted odds ratio 3.84; 95% CI 1.03, 14.50). MEMS adherence ≥90% was similar for participants with high vs. low discount rates (42.3% vs. 49.6%, AOR 0.70; 95% CI 0.40, 1.25).ConclusionHigh discount rates were associated with significantly higher risk of mortality among HIV-infected patients initiating ART. Greater use of time preference measures may improve identification of patients at risk of poor clinical outcomes. More research is needed to further identify mechanisms of action and also to build upon and test the generalizability of this finding.

Pregnancy rates in HIV-positive women using contraceptives and efavirenz-based or nevirapine-based antiretroviral therapy in Kenya: a retrospective cohort study

SUMMARYBackgroundGiven recent concerns of efavirenz reducing the efficacy of contraceptive implants, we sought to determine if pregnancy rates differ among HIV-positive women using various contraceptive methods and efavirenz- or nevirapine-based antiretroviral therapy (ART) regimens.MethodsWe conducted a retrospective cohort analysis of HIV-positive women aged 15–45 years enrolled in HIV care facilities in western Kenya from January 2011 to December 2013. Pregnancy was diagnosed clinically and the primary exposure was a combination of contraceptive method and ART regimen. We used Poisson models, adjusting for repeated measures, as well as demographic, behavioral and clinical factors, to compare pregnancy rates among women on different contraceptive/ART combinations.Findings24,560 women contributed 37,635 years of follow-up with 3,337 incident pregnancies. Among women using implants, adjusted pregnancy incidence for nevirapine- and efavirenz-based ART users were 1·1 (95% CI 0·72–1·5) and 3·3 (95% CI 1·8–4·8) per 100 women-years (w-y), respectively (adjusted incidence rate ratio (aIRR) 3·0, 95% CI 1·3–4·6). Among women using depomedroxyprogesterone acetate (DMPA), adjusted pregnancy incidence for nevirapine- and efavirenz-based ART users were 4·5 (95% CI 3·7–5·2) and 5·4 (95% CI 4·0–6·8) per 100 w-y, respectively (aIRR 1·2, 95% CI 0·91–1·5). Women using other contraceptive methods, except for intrauterine devices and permanent methods, experienced 3·1–4·1 higher rates of pregnancy than women using implants, with 1·6–2·8 higher rates specifically among women using efavirenz-based ART.InterpretationWhile HIV-positive women using implants on efavirenz-based ART faced three times higher risk of contraceptive failure than those on nevirapine-based ART, these women still experienced lower contraceptive failure rates than women on all other contraceptive methods, except for intrauterine devices and permanent methods. Guidelines for contraceptive and ART combinations should balance the failure rates for each contraceptive method and ART regimen combination against the high effectiveness of implants.FundingSupported by the President’s Emergency Plan for AIDS Relief and the Centers for Disease Control and Prevention.

Nurse-led palliative care for HIV-positive patients taking antiretroviral therapy in Kenya: a randomised controlled trial

People with HIV accessing antiretroviral therapy (ART) have persistent physical, psychological, social, and spiritual problems, which are associated with poor quality of life and treatment outcomes. We assessed the effectiveness of a nurse-led palliative care intervention on patient-reported outcomes. We did this randomised controlled trial at a clinic in Kenya for adults with HIV, established on ART, and reporting moderate-to-severe pain or symptoms. We randomly assigned participants (1:1) either to a palliative care intervention (including assessments of physical, emotional, and spiritual wellbeing and quality of life) given six times over 4 months, or to usual care. Participants and investigators were not masked to allocation. The primary outcome was pain (scored on the African Palliative Care Association's African Palliative Outcome Scale). This trial is registered with ClinicalTrials.gov, number NCT01608802. We screened 2070 patients, of whom we enrolled 120: 60 allocated to each group. In the control group, median pain score improved from 1·0 (IQR 0·0-2·0) at baseline to 5·0 (3·0-5·0) at 4 months; in the intervention group, it improved from 1·0 (0·0-2·0) at baseline to 4·5 (3·0-5·0) at 4 months. Compared with standard care, the intervention had no significant effect on pain (coefficient -0·01, 95% CI -0·36 to 0·34, p=0·95). A nurse-led palliative care intervention was not effective in reducing pain. However, person-centred assessment and care delivered by staff who have received additional training had positive effects on self-reported mental health related quality of life and psychosocial wellbeing. Diana Princess of Wales Memorial Fund.

Uptake of WHO recommendations for first-line antiretroviral therapy in Kenya, Uganda, and Zambia.

IntroductionAntiretroviral therapy (ART) guidelines were significantly changed by the World Health Organization in 2010. It is largely unknown to what extent these guidelines were adopted into clinical practice.MethodsThis was a retrospective observational analysis of first-line ART regimens in a sample of health facilities providing ART in Kenya, Uganda, and Zambia between 2007-2008 and 2011-2012. Data were analyzed for changes in regimen over time and assessed for key patient- and facility-level determinants of tenofovir (TDF) utilization in Kenya and Uganda using a mixed effects model.ResultsData were obtained from 29,507 patients from 146 facilities. The overall percentage of patients initiated on TDF-based therapy increased between 2007-2008 and 2011-2012 from 3% to 37% in Kenya, 2% to 34% in Uganda, and 64% to 87% in Zambia. A simultaneous decrease in stavudine (d4T) utilization was also noted, but its use was not eliminated, and there remained significant variation in facility prescribing patterns. For patients initiating ART in 2011-2012, we found increased odds of TDF use with more advanced disease at initiation in both Kenya (odds ratio [OR]: 2.78; 95% confidence interval [CI]: 1.73-4.48) and Uganda (OR: 2.15; 95% CI: 1.46-3.17). Having a CD4 test performed at initiation was also a significant predictor in Uganda (OR: 1.43; 95% CI: 1.16-1.76). No facility-level determinants of TDF utilization were seen in Kenya, but private facilities (OR: 2.86; 95% CI: 1.45-5.66) and those employing a doctor (OR: 2.86; 95% CI: 1.48-5.51) were more likely to initiate patients on TDF in Uganda.Discussiond4T-based ART has largely been phased out over the study period. However, significant in-country and cross-country variation exists. Among the most recently initiated patients, those with more advanced disease at initiation were most likely to start TDF-based treatment. No facility-level determinants were consistent across countries to explain the observed facility-level variation.

Time Preferences Predict Mortality among HIV-Infected Adults Receiving Antiretroviral Therapy in Kenya

Time Preferences Predict Mortality among HIV-Infected Adults Receiving Antiretroviral Therapy in Kenya