Impact of Moringa oleifera lam. Leaf powder supplementation versus nutritional counseling on the body mass index and immune response of HIV patients on antiretroviral therapy: a single-blind randomized control trial.

BACKGROUND: To achieve effective antiretroviral therapy (ART) outcomes, adherence to an antiretroviral regimen and a good immunometabolic response are essential. Food insecurity can act as a real barrier to adherence to both of these factors. Many people living with human immunodeficiency virus (PLHIV) treated with ART in the Democratic Republic of the Congo (DRC) are faced with nutritional challenges. A significant proportion are affected by under nutrition, which frequently leads to therapeutic failure. Some HIV care facilities recommend supplementation with Moringa oleifera (M.O.) Lam. leaf powder to combat marginal and major nutritional deficiencies. This study aims to assess the impact of M.O. Lam. leaf powder supplementation compared to nutritional counseling on the nutritional and immune status of PLHIV treated with ART. METHODS: A single-blind randomized control trial was carried out from May to September 2013 at an outpatient clinic for HIV-infected patients in Kinshasa (DRC). Sixty adult patients who were at stable HIV/AIDS clinical staging 2, 3 or 4 according to the World Health Organization (WHO), and were undergoing ART were recruited. After random allocation, 30 patients in the Moringa intervention group (MG) received the M.O. Lam. leaf powder daily over 6 months, and 30 in the control group (CG) received nutritional counseling over the same period. Changes in the body mass index (BMI) were measured monthly and biological parameters were measured upon admission and at the end of the study for the patients in both groups. RESULTS: The two study groups were similar in terms of long-term nutritional exposure, sociodemographic, socioeconomic, clinical, and biological features. At 6 months follow-up, patients in the MG exhibited a significantly greater increase in BMI and albumin levels than those in the CG. The interaction between the sociodemographic, clinical, and biological characteristics of patients in the two groups was not significant, with the exception of professional activity. CONCLUSIONS: Under medical supervision, M.O. Lam. leaf powder supplementation may represent a readily available and effective local solution to improve the nutritional intake and nutritional status of PLHIV undergoing ART. TRIAL REGISTRATION: The study was retrospectively registered in the Pan African Clinical Trial Registry on 15 May 2015, no. PACTR201505001076143.

HIV infection among children and adolescents in Burundi, Cameroon, and the Democratic Republic of Congo.

Evidence demonstrates a substantial HIV epidemic among children and adolescents in countries with long-standing generalized HIV epidemics, where availability of prevention of mother-to-child transmission services has historically been limited. The objective of this research was to explore factors associated with antiretroviral therapy (ART) initiation and morbidity among HIV-infected surviving children 2-17 years of age attending HIV programs in Central Africa. Programmatic data from 404 children attending HIV programs in Burundi, Cameroon, and the Democratic Republic of Congo (DRC) were included in our evaluation. Children were followed prospectively from 2008 to 2011 according to each clinic's standard of care. Diagnosis at a reference hospital was significantly associated with not having initiated ART (adjusted odds ratio, AOR = 0.40; 95% confidence interval, CI, 0.24-0.67). Being seen at a clinic in Cameroon (AOR = 0.45; 95%CI = 0.24-0.85) and being in school were associated with decreased risk (AOR = 0.55; 95%CI = 0.31-0.96). Being ART-naïve (AOR = 1.88; 95%CI = 1.20-2.94) and being diagnosed at a reference hospital (AOR = 2.39; 95%CI = 1.29-4.41) or other testing facility (AOR = 2.86; 95%CI = 1.32-6.18) were associated with increased risk of having a morbid event at the initial visit. In longitudinal analysis of incident morbidity, we found a decreased risk associated with attending clinics in Cameroon (adjusted hazard ratio, AHR = 0.23; 95%CI = 0.11-0.46) and the DRC (AHR = 0.46; 95%CI = 0.29-0.74), and an increased risk associated with being ART-naïve (AHR = 1.83; 95%CI = 1.12-2.97). We found a high burden of HIV-related health problems among children receiving care in this setting. Children face significant barriers to accessing HIV services, and the HIV epidemic among surviving children in the Central African region has not been adequately evaluated nor addressed.

HIV seropositivity and sexuality: cessation of sexual relations among men and women living with HIV in five countries.

The sexuality of people living with HIV (PLHIV) is a key issue in the fight against HIV, as it influences both the dynamic of the epidemic and the quality of life of PLHIV. The present study examined the factors associated with cessation of sexual relations after HIV diagnosis among men and women in five countries: Mali, Morocco, Democratic Republic of the Congo, Romania and Ecuador. A community-based cross-sectional study was implemented by a mixed consortium [researchers/community-based organizations (CBO)]. Trained CBO members interviewed 1500 PLHIV in contact with CBOs using a 125-item questionnaire. A weighted multivariate logistic regression and a separate gender analysis were performed. Among the 1413 participants, 471 (33%) declared that they stopped having sexual relations after their HIV diagnosis, including 318 women (42%) and 153 men (23%) (p < .001). Concerning women, variables associated with the cessation of sexual relations in the final multivariate model were mainly related with relational factors and the possibility of getting social support (e.g., needing help to disclose HIV serostatus, feeling lonely every day, not finding support in CBOs, not being in a couple). Men's sexual activity was more associated with their representations and their perception of the infection (e.g., thinking they will have their HIV infection for the rest of their life, perceiving the HIV infection as a mystery, perceiving the infection as serious). Furthermore, the following variables were associated with both men and women sexual behaviours: being older, having suffered from serious social consequences after serostatus disclosure and not being able to regularly discuss about HIV with their steady partner. Results suggested clear differences between men and women regarding cessation of sexual relations and highlighted the importance of implementing gender-based tailored interventions that promote safe and satisfying sexuality, as it is known to have a positive impact on the overall well-being of PLHIV.

Characteristics of antiretroviral therapy-naïve patients lost-to-care in HIV clinics in Democratic Republic of Congo, Cameroon, and Burundi.

Antiretroviral therapy (ART)-naïve patients are vulnerable to becoming lost-to-care (LTC) because they are not monitored as often as patients on treatment. We examined data from 19,461 HIV positive adults at 10 HIV clinics in Democratic Republic of Congo (DRC), Cameroon, and Burundi participating in the Phase 1 International epidemiologic Databases to Evaluate AIDS Central Africa (IeDEA-CA) study. Patients were LTC if they were ART-naïve and did not return within 7 months of the end of data collection. Logistic regression was used to obtain odds ratios (ORs) and 95% confidence intervals (CIs) for risk factors associated with LTC. Of 5353 ART-naïve patients, 4420 (83%) were LTC and 933 (17%) were in-care. The odds of being LTC were greatest among patients from DRC (OR = 2.16, CI: 1.64-2.84, p < .0001), males (OR = 1.39, CI: 1.15-1.69, p = .0009), and ages 18-49 (OR = 1.45, CI: 1.16-1.82, p = .001). The odds of being LTC were least among patients with a WHO Clinical Stage of 1 or 2 (OR = 0.65, CI: 0.55-0.77, p < .0001) and in a perceived concordant relationship (OR = 0.61, CI: 0.43-0.87, p < .0001). LTC patients were more likely to have characteristics associated with higher risk for HIV transmission and progression. Many entered care at advanced stages and were less likely to know their partner's serostatus. Greater efforts to retain ART-naïve patients may increase earlier initiation of ART.

Patient outcomes in Lubumbashi, Democratic Republic of Congo after a disruption in HIV care due to decreased global fund appropriations.

This study examines care seeking behaviors, clinical outcomes, and satisfaction with care of HIV-positive adults in Lubumbashi, DRC, one year after a disruption in care due to decreased global fund appropriations. We describe outcomes before and after the disruption. We compared characteristics of those who completed the survey and those who did not using the Wald F test. Most patients sought care after the disruption and continued antiretroviral therapy (ART), though use of cotrimoxizole prophylaxis declined. Though there was little change in WHO clinical stage at the new site of care, the majority of participants lost weight, adherence decreased, support group participation dropped, and satisfaction with care worsened. Patients were more likely to participate in the study if they were taking ART. This study highlights the importance of provider-patient communication during a transfer and the vulnerability of pre-ART patients to becoming lost to follow-up.

Adult HIV care resources, management practices and patient characteristics in the Phase 1 IeDEA Central Africa cohort.

INTRODUCTION: Despite recent advances in the management of HIV infection and increased access to treatment, prevention, care and support, the HIV/AIDS epidemic continues to be a major global health problem, with sub-Saharan Africa suffering by far the greatest humanitarian, demographic and socio-economic burden of the epidemic. Information on HIV/AIDS clinical care and established cohorts' characteristics in the Central Africa region are sparse. METHODS: A survey of clinical care resources, management practices and patient characteristics was undertaken among 12 adult HIV care sites in four countries of the International Epidemiologic Databases to Evaluate AIDS Central Africa (IeDEA-CA) Phase 1 regional network in October 2009. These facilities served predominantly urban populations and offered primary care in the Democratic Republic of Congo (DRC; six sites), secondary care in Rwanda (two sites) and tertiary care in Cameroon (three sites) and Burundi (one site). RESULTS: Despite some variation in facility characteristics, sites reported high levels of monitoring resources, including electronic databases, as well as linkages to prevention of mother-to-child HIV transmission programs. At the time of the survey, there were 21,599 HIV-positive adults (median age=37 years) enrolled in the clinical cohort. Though two-thirds were women, few adults (6.5%) entered HIV care through prevention of mother-to-child transmission services, whereas 55% of the cohort entered care through voluntary counselling and testing. Two-thirds of patients at sites in Cameroon and DRC were in WHO Stage III and IV at baseline, whereas nearly all patients in the Rwanda facilities with clinical stage information available were in Stage I and II. WHO criteria were used for antiretroviral therapy initiation. The most common treatment regimen was stavudine/lamivudine/nevirapine (64%), followed by zidovudine/lamivudine/nevirapine (19%). CONCLUSIONS: Our findings demonstrate the feasibility of establishing large clinical cohorts of HIV-positive individuals in a relatively short amount of time in spite of challenges experienced by clinics in resource-limited settings such as those in this region. Country differences in the cohort's site and patient characteristics were noted. This information sets the stage for the development of research initiatives and additional programs to enhance adult HIV care and treatment in Central Africa.

Retention in a NGO supported antiretroviral program in the Democratic Republic of Congo.

BACKGROUND: Retention of patients in ART care is a major challenge in sub-Saharan programs. Retention is also one of the key indicators to evaluate the success of ART programs. METHODS AND FINDINGS: A retrospective review of 1500 randomly selected medical charts of adult ART patients from a local non-governmental (NGO) supported ART program in the Democratic Republic of Congo (DRC). Retention was defined as any visit to the clinic in the 4 months prior to the abstraction date. Retention over time and across different sites was described. The relationship between patient characteristics and retention rates at 1 year was also examined. 1450 patients were included in the analysis. The overall retention rates were 81.4% (95% CI: 79.3-83.4), 75.2% (95% CI: 72.8-77.3), 65.0% (95% CI: 62.3-67.6) and 57.2% (95% CI: 54.0-60.3) at 6 months, 1 year, 2 years and 3 years respectively. The retention rates between sites varied between 62.1% and 90.6% at 6 months and between 55.5% and 86.2% at 1 year. During multivariable analysis weight below 50 kg (aHR: 1.33, 95%CI: 1.05-1.69), higher WHO stage at initiation (aHR: 1.22, 95%CI 0.85-1.76 for stage 3 and aHR: 2.98, 95%CI: 1.93-4.59 for stage 4), and male sex (aHR: 1.32, 95%CI: 1.05-1.65) remained as significant risk factors for attrition during the first year after ART initiation. Other independent risk factors were year of initiation (aHR: 1.73, 95%CI: 1.26-2.38 for the year 2007 and aHR: 3.06, 95%CI: 2.26-4.14 for the period 2008-2009), and site. CONCLUSIONS: Retention is a major problem in DRC, while coverage of patients on ART is still very low. With the flattening of funding for HIV care and treatment in sub-Saharan Africa, and with decreasing funding worldwide, maximizing retention during the much needed scaling-up will even be more important.

Older Adults Accessing HIV Care and Treatment and Adherence in the IeDEA Central Africa Cohort.

Background. Very little is known about older adults accessing HIV care in sub-Saharan Africa. Materials and Methods. Data were obtained from 18,839 HIV-positive adults at 10 treatment programs in Burundi, Cameroon, and the Democratic Republic of Congo. We compared characteristics of those aged 50+ with those aged 18-49 using chi-square tests. Logistic regression was used to determine if age was associated with medication adherence. Results. 15% of adults were 50+ years. Those aged 50+ were more evenly distributed between women and men (56% versus 44%) as compared to those aged 18-49 (71% versus 29%) and were more likely to be hypertensive (8% versus 3%) (P < 0.05). Those aged 50+ were more likely to be adherent to their medications than those aged 18-49 (P < 0.001). Adults who were not heavy drinkers reported better adherence as compared to those who reported drinking three or more alcoholic beverages per day (P < 0.001). Conclusions. Older adults differed from their younger counterparts in terms of medication adherence, sociodemographic, behavioral, and clinical characteristics.

Prevalence of low estimated glomerular filtration rate, proteinuria, and associated risk factors among HIV-infected black patients using Cockroft-Gault and modification of diet in renal disease study equations.

OBJECTIVE: To evaluate the prevalence of low estimated glomerular filtration rate (eGFR), proteinuria, and associated risk factors among HIV-infected black patients at primary health care. METHODS: A cross-sectional screening involving consecutive HIV-infected patients 18 years and older was done. Eighty-eight percent of patients were receiving highly active antiretroviral therapy (94% on first-line regimen: zidovudine + lamivudine + nevirapine). Simplified Modification of Diet in Renal Disease Study and Cockroft-Gault (CG) equations were used to estimate glomerular filtration rate and creatinine clearance, respectively. Determinants of dipstick proteinuria and low kidney function (<60 mL·min(-1)·1.73 m(-2)) were assessed using multivariate logistic regression analysis. RESULTS: Three hundred HIV-infected (231 females) patients were screened. Their mean age, duration of HIV, and CD4(+) count were 43 ± 9 years, 33 ± 27 months, and 397 ± 224 cells per cubic millimeter, respectively. The prevalence of low eGFR according to Modification of Diet in Renal Disease Study and CG equations was 3% and 10%, respectively. Proteinuria was observed in 20.5% of patients. Only CD4(+) cell count ≤200 cells per cubic millimeter emerged as a strong determinant of low CG creatinine clearance [adjusted odds ratio (OR) 3.03; 95% confidence interval (CI): 1.099 to 8.352], whereas age ≥45 years (adjusted OR 3.69; 95% CI: 1.756 to 7.787), familial history of diabetes mellitus (adjusted OR 2.20; 95% CI: 1.067 to 4.543), and hypertension (adjusted OR 3.07; 95% CI: 1.278 to 7.787) were significantly associated with proteinuria. CONCLUSIONS: Low eGFR and proteinuria are prevalent among these HIV-infected persons. Immunodeficiency emerged as one of the strongest determinants of renal impairment. This finding emphasizes the importance of highly active antiretroviral therapy in tackling the burden of chronic kidney disease in African HIV population.

Universal definition of loss to follow-up in HIV treatment programs: a statistical analysis of 111 facilities in Africa, Asia, and Latin America.

BACKGROUND: Although patient attrition is recognized as a threat to the long-term success of antiretroviral therapy programs worldwide, there is no universal definition for classifying patients as lost to follow-up (LTFU). We analyzed data from health facilities across Africa, Asia, and Latin America to empirically determine a standard LTFU definition. METHODS AND FINDINGS: At a set "status classification" date, patients were categorized as either "active" or "LTFU" according to different intervals from time of last clinic encounter. For each threshold, we looked forward 365 d to assess the performance and accuracy of this initial classification. The best-performing definition for LTFU had the lowest proportion of patients misclassified as active or LTFU. Observational data from 111 health facilities-representing 180,718 patients from 19 countries-were included in this study. In the primary analysis, for which data from all facilities were pooled, an interval of 180 d (95% confidence interval [CI]: 173-181 d) since last patient encounter resulted in the fewest misclassifications (7.7%, 95% CI: 7.6%-7.8%). A secondary analysis that gave equal weight to cohorts and to regions generated a similar result (175 d); however, an alternate approach that used inverse weighting for cohorts based on variance and equal weighting for regions produced a slightly lower summary measure (150 d). When examined at the facility level, the best-performing definition varied from 58 to 383 d (mean=150 d), but when a standard definition of 180 d was applied to each facility, only slight increases in misclassification (mean=1.2%, 95% CI: 1.0%-1.5%) were observed. Using this definition, the proportion of patients classified as LTFU by facility ranged from 3.1% to 45.1% (mean=19.9%, 95% CI: 19.1%-21.7%). CONCLUSIONS: Based on this evaluation, we recommend the adoption of ≥180 d since the last clinic visit as a standard LTFU definition. Such standardization is an important step to understanding the reasons that underlie patient attrition and establishing more reliable and comparable program evaluation worldwide. Please see later in the article for the Editors' Summary.