Comparison of HIV-1 detection in plasma specimens and dried blood spots using the Roche COBAS Ampliscreen HIV-1 test in Kisumu, Kenya.

The World Health Organization recommends screening donor blood for HIV in centralized laboratories. This recommendation contributes to quality, but presents specimen transport challenges for resource-limited settings which may be relieved by using dried blood spots (DBS). In sub-Saharan Africa, most countries screen donor blood with serologic assays only. Interest in window period reduction has led blood services to consider adding HIV nucleic acid testing (NAT). The U.S. Food and Drug Administration (FDA) mandates that HIV-1 NAT blood screening assays have a 95% detection limit at or below 100 copies/ml and 5000 copies/ml for pooled and individual donations, respectively. The Roche COBAS Ampliscreen HIV-1 test, version 1.5, used for screening whole blood or components for transfusion, has not been tested with DBS. We compared COBAS Ampliscreen HIV-1 RNA detection limits in DBS and plasma. An AIDS Clinical Trials Group, Viral Quality Assurance laboratory HIV-1 standard with a known viral load was used to create paired plasma and DBS standard nine member dilution series. Each was tested in 24 replicates with the COBAS Ampliscreen. A probit analysis was conducted to calculate 95% detection limits for plasma and DBS, which were 23.8 copies/ml (95% CI 15.1-51.0) for plasma and 106.7 copies/ml (95% CI 73.8-207.9) for DBS. The COBAS Ampliscreen detection threshold with DBS suggests acceptability for individual donations, but optimization may be required for pooled specimens.

Site factors may be more important than participant factors in explaining HIV test acceptance in the prevention of mother-to-child HIV transmission programme in Kenya, 2005.

OBJECTIVE: To determine the role of participant factors on the acceptance of a Prevention-of-Mother-to-Child (PMTCT) HIV test programme in a situation with an opt-out testing strategy. METHODS: We analysed antenatal clinic (ANC) HIV sentinel surveillance data. All 43 sites in the 2005 round of Kenya's ANC surveillance offered opt-out PMTCT services and recorded if women were offered PMTCT HIV testing and whether they accepted or refused. Logistic regression was used to determine the role of participant-level factors on PMTCT acceptance. RESULTS: During the period of sentinel surveillance, 13,026 women attended ANC and testing was offered to 12,030 women. Of those offered testing, 9690 (80.5%) accepted, with a large variation in the percent of acceptors by site. Age, residence and educational status were significant determinants of PMTCT acceptance. However, after adjusting for site none of the participant-level factors were significant determinants of PMTCT acceptance. CONCLUSIONS: Participant level factors were not significant determinants of PMTCT HIV test acceptance after adjusting for sites. PMTCT programmes should collect and evaluate the role of site-level (provider and testing service) factors on PMTCT acceptance. Improvement of site-level factors could improve PMTCT uptake.

Knowledge of HIV status, sexual risk behaviors and contraceptive need among people living with HIV in Kenya and Malawi.

BACKGROUND: Several studies support the need for effective interventions to reduce HIV transmission risk behaviors among people living with HIV/AIDS (PLWHAs). DESIGN: Cross-sectional nationally representative demographic health survey of Kenya (2003) and Malawi (2004-2005) that included HIV testing for consenting adults. METHODS: We analyzed demographic health survey data for awareness of HIV status and sexual behaviors of PLWHAs (Kenya: 412; Malawi: 664). The analysis was adjusted (weighted) for the design of the survey and the results are nationally representative. FINDINGS: Eighty-four percent of PLWHAs in Kenya and 86% in Malawi had sex in the past 12 months and in each country, 10% reported using condoms at last intercourse. Among sexually active PLWHAs, 86% in Kenya and 96% in Malawi reported their spouse or cohabiting partner as their most recent partner. In multivariate logistic regression models, married or cohabiting PLWHAs were significantly more likely to be sexually active and less likely to use condoms. Over 80% of PLWHAs were unaware of their HIV status. Of HIV-infected women, nearly three-quarters did not want more children either within the next 2 years or ever, but 32% in Kenya and 20% in Malawi were using contraception. INTERPRETATION: In 2003-2005, majority of PLWHAs in Kenya and Malawi were unaware of their HIV status and were sexually active, especially married or cohabiting PLWHAs. Of HIV-infected women not wanting more children, few used contraception. HIV testing should be expanded, prevention programs should target married or cohabiting couples and family planning services should be integrated with HIV services.

Utility of antenatal HIV surveillance data to evaluate prevention of mother-to-child HIV transmission programs in resource-limited settings.

Prevention of mother-to-child human immunodeficiency virus (HIV) transmission (PMTCT) programs are expanding in resource-limited countries and are increasingly implemented in antenatal clinics (ANC) in which HIV sentinel surveillance is conducted. ANC sentinel surveillance data can be used to evaluate the first visit of a pregnant woman to PMTCT programs. We analyzed data from Kenya and Ethiopia, where information on PMTCT test acceptance was collected on the 2005 ANC sentinel surveillance forms. For Zimbabwe, we compared the 2005 ANC sentinel surveillance data to the PMTCT program data. ANC surveillance data allowed us to calculate the number of HIV-positive women not participating in the PMTCT program. The percentage of HIV-positive women missed by the PMTCT program was 17% in Kenya, 57% Ethiopia, and 59% Zimbabwe. The HIV prevalence among women participating in PMTCT differed from women who did not. ANC sentinel surveillance can be used to evaluate and improve the first encounter in PMTCT programs. Countries should collect PMTCT-related program data through ANC surveillance to strengthen the PMTCT program.

Developing a nursing database system in Kenya.

OBJECTIVE: To describe the development, initial findings, and implications of a national nursing workforce database system in Kenya. PRINCIPAL FINDINGS: Creating a national electronic nursing workforce database provides more reliable information on nurse demographics, migration patterns, and workforce capacity. Data analyses are most useful for human resources for health (HRH) planning when workforce capacity data can be linked to worksite staffing requirements. As a result of establishing this database, the Kenya Ministry of Health has improved capability to assess its nursing workforce and document important workforce trends, such as out-migration. Current data identify the United States as the leading recipient country of Kenyan nurses. The overwhelming majority of Kenyan nurses who elect to out-migrate are among Kenya's most qualified. CONCLUSIONS: The Kenya nursing database is a first step toward facilitating evidence-based decision making in HRH. This database is unique to developing countries in sub-Saharan Africa. Establishing an electronic workforce database requires long-term investment and sustained support by national and global stakeholders.

Predictors of treatment error for children with uncomplicated malaria seen as outpatients in Blantyre district, Malawi.

BACKGROUND: Past studies have shown that health workers in developing countries often do not follow clinical guidelines, though few studies have explored with appropriate methods why errors occur. To develop interventions that improve health worker performance, factors affecting treatment practices must be better understood. METHODS: We analysed data from a health facility survey in Blantyre District, Malawi, in which health workers were observed treating ill children, and then children were independently re-examined by 'gold-standard' study clinicians. The analysis was limited to children with uncomplicated malaria (defined according to Malawi's guidelines as fever or anaemia without signs of severe illness), and a treatment error was defined as failure to treat with an effective antimalarial. RESULTS: Twenty-eight health workers and 349 ill-child consultations were evaluated; 247 (70.8%) children were treated with an effective antimalarial, and 102 (29.2%) were subject to treatment error. Logistic regression analysis revealed that in-service malaria training was not associated with treatment quality (univariate odds ratio (OR) = 1.16, 95% confidence interval (CI): 0.46-2.93); whereas acute respiratory infections training was associated with making an error (adjusted OR (aOR) = 2.42, 95% CI: 1.23-4.76). High fever and chief complaint of fever were associated with fewer errors (aOR = 0.25, 95% CI: 0.10-0.60 and aOR = 0.25, 95% CI: 0.13-0.48, respectively). Errors were more likely to occur in consultations starting before 1 p.m. (aOR = 1.88, 95% CI: 1.07-3.31). Supervision was not associated with better treatment quality. CONCLUSIONS: These results suggest that the disease-specific training and supervision, performed before the survey, did not lead to long-term improvements in health care quality. Furthermore, case management training for one specific disease may have worsened quality of care for another disease. These results support integration of guidelines for multiple conditions. Interventions should be evaluated for unintended negative effects on overall quality of care.

Preventing mother-to-child transmission of HIV in Western Kenya: operational issues.

OBJECTIVES: To improve uptake in a program to prevent mother-to-child HIV transmission and describe lessons relevant for prevention of mother-to-child transmission programs in resource-poor settings. METHODS: Implementation of a pilot project that evaluates approaches to increase program uptake at health facility level at New Nyanza Provincial General Hospital, a public hospital in western Kenya, an area with high HIV prevalence. Client flow was revised to integrate counseling, HIV testing, and dispensing of single-dose nevirapine into routine antenatal services. The number of facilities providing PMCT services was expanded to increase district-wide coverage. Main outcome measures were uptake of counseling, HIV testing, nevirapine, and estimated program impact. RESULTS: Uptake of counseling and testing improved from 55 to 68% (P < 0.001), nevirapine uptake from 57% to 70% (P < 0.001), and estimated program impact from 15% to 23% (P = 0.03). Aggregate reports compare well with computer-entered data. CONCLUSION: Addressing institutional factors can improve uptake, but expected program impact remains low for several reasons, including relatively low efficacy of the intervention and missed opportunities in the labor room.

Prevention of mother-to-child transmission and voluntary counseling and testing programme data: what is their utility for HIV surveillance?

OBJECTIVE: Antenatal clinic (ANC)-based surveillance through unlinked anonymous testing (UAT) for HIV without informed consent provides solid long-term trend data in resource-constrained countries with generalized epidemics. The rapid expansion of the prevention of mother-to-child transmission (PMTCT) and voluntary counseling and testing (VCT) programmes prompts the question regarding their utility for HIV surveillance and their potential to replace UAT-based ANC surveillance. METHODS: Four presentations on the use of PMTCT or VCT data for HIV surveillance were presented at a recent international conference. The main findings are presented in this paper, and the operational and epidemiological aspects of using PMTCT or VCT data for surveillance are considered. RESULTS: VCT data in Uganda confirm the falling trend in HIV prevalence observed in ANC surveillance. Thailand, a country with nationwide PMTCT coverage and a very high acceptance of HIV testing, has replaced UAT data in favor of PMTCT data for surveillance. Studies from Botswana and Kenya showed that PMTCT-based HIV prevalences was similar, but the quality and availability of the PMTCT data varied. CONCLUSION: The strength of UAT lies in the absence of selection bias and the availability of individual data. Conversely, the quantity of VCT and PMTCT programme testing data often exceed those in UAT, but may be subject to bias due to self-selection or test refusal. When using VCT or PMTCT data for surveillance, investigators must consider these caveats, as well as their varying data quality, accessibility, and availability of individual records.

Lessons learned in the conduct, validation, and interpretation of national population based HIV surveys.

In the past few years several countries have conducted national population-based HIV surveys. Survey methods, levels of participation bias from absence or refusal and lessons learned conducting such surveys are compared in four national population surveys: Mali, Kenya, Peru and Zambia. In Mali, Zambia, and Kenya, HIV testing of adult women and men was included in the national-level demographic and health surveys carried out regularly in these countries, whereas in Peru the national HIV survey targeted young people in 24 cities with populations over 50 000.The household response rate was above 90% in all countries, but some individuals were absent for interviews. HIV testing rates were between 70 and 79% of those eligible, with higher test rates for women. Three critical questions in this type of survey need to be answered: who did the surveys miss; how much it matters that they were missed; and what can be done to increase the participation of respondents so the coverage rates are adequate. The level of representativeness of the populations tested was adequate in each survey to provide a reliable national estimate of HIV prevalence that complements other methods of HIV surveillance. Different lessons were learned from each survey. These population-based HIV seroprevalence surveys demonstrate that reliable and useful results can be obtained, although they require careful planning and increased financial and human resource investment to maximize responses at the household and individual level, which are key elements to validate survey results.This review was initiated through an international meeting on 'New strategies for HIV/AIDS Surveillance in Resource-constrained Countries' held in Addis Ababa on 26-30 January 2004 to share and develop recommendations to guide future surveys.

Changing patterns in sexually transmitted disease syndromes in Kenya after the introduction of a syndromic management program.

OBJECTIVE: The objective of this study was to evaluate patterns in sexually transmitted disease (STD) syndromes after the introduction of an STD syndromic management program. STUDY: We used the HIV sentinel surveillance in patients with STDs (1990-2001) to compute the proportions of STD syndromes (as a proportion of all patients with STDs) before and after the introduction of the syndromic management program. RESULTS: A decline in the proportion of genital ulcer disease (GUD), urethral discharge (UD), and vaginal discharge (VD) was observed from the baseline (1990-1994) to the year 2000 (P <0.0001). GUD declined from 27.6% at baseline to 11.0% in 2000; UD from 31.8% at baseline to 22.2% in 2000; and VD from 36.7% at baseline to 20.1% in 2000. Similar declines for these syndromes were also observed in sex and age groups. The proportions of GUD, UD, and UV increased again in 2001. CONCLUSIONS: These changing patterns of STD syndromes were coincident with the introduction of the STD syndromic management program in 1995 and the termination of free STD medication in 2001.

Use of antenatal care services and intermittent preventive treatment for malaria among pregnant women in Blantyre District, Malawi.

Malaria in pregnancy contributes to low birth weight and increased infant mortality. As part of WHO's Roll Back Malaria initiative, African heads of state pledged that by 2005, 60% of pregnant women will receive malaria chemoprophylaxis or intermittent preventive treatment (IPT). We performed a cluster sample survey to study the use of sulfadoxine-pyrimethamine (SP) for IPT among recently pregnant women in February 2000 in Blantyre District, Malawi. Among 391 women in the sample, 98.6% had attended antenatal clinic at least once and 90.2% knew that SP/IPT was recommended during pregnancy. Overall, only 36.8% received the full recommended two-dose regimen of SP/IPT. Using data from 187 women with antenatal clinic cards, we found that residence location, housing type and gender/age/education of the head of household were not associated with failure to receive SP/IPT. Adjusting for education, multigravid women were more likely not to receive the recommended SP/IPT regimen (RR 1.2, 95% CI 1.02-1.5, P=0.03). A substantial effort to improve the delivery and use of SP/IPT in Malawi will be necessary, but the Roll Back Malaria 2005 goal appears achievable.

Care seeking behaviour and treatment of febrile illness in children aged less than five years: a household survey in Blantyre District, Malawi.

Malaria is a leading cause of death in children aged < 5 years in Malawi. As part of the Roll Back Malaria initiative, African heads of state have pledged that by 2005, 60% of children will receive an effective antimalarial drug within 24 h of developing fever. In 1993, Malawi switched from chloroquine to sulfadoxine-pyrimethamine (SP) in its recommendations of home treatment of febrile illness in children. To study care seeking behaviour and home treatment in Blantyre District, and provide valuable follow-up to the chloroquine to SP transition, we performed a 2-stage cluster-sample survey in February 2000. Our sample of 1080 households included 672 households with children aged < 5 years; 292 (32.2%, 95% CI 28.7-35.8%) of the 912 children in these households had completed a febrile episode within the past 14 d. Among recently febrile children, 210 (72.0%, 95% CI 67.0-77.1%) received medication at home during their illness, but only 36 (12.2%, 95% CI 8.4-16.0%) received an appropriate antimalarial drug. Overall, 111 (37.4%, 95% CI 30.9-43.9%) received prompt, appropriate treatment. Only rural location was statistically associated with failure to receive prompt appropriate treatment (risk ratio estimate 1.2, 95% CI 1.01-1.5). A greater effort to improve the quality of malaria home treatment or to expand health facility utilization will be necessary to achieve Roll Back Malaria goals before 2005 in Blantyre District. Current care seeking practices suggest interventions should stress promptness of health facility visits, improved access to appropriate drugs, and accurate dosing for home-based treatments.

Phase I/II trial of HIV-1 hyperimmune globulin for the prevention of HIV-1 vertical transmission in Uganda.

OBJECTIVES: To assess the safety, tolerance, pharmacokinetics, and virologic and immunologic changes associated with the use of Ugandan HIV hyperimmune globulin (HIVIGLOB) in HIV infected pregnant Ugandan women and their infants. DESIGN: A prospective, phase I/II, three-arm dose escalation trial of HIVIGLOB. METHODS: HIVIGLOB was prepared from discarded HIV infected units of blood collected from the National Blood Bank in Kampala. From June 1996 to April 1997, 31 HIV positive pregnant women were enrolled with HIVIGLOB infusions given at 37 weeks gestation and within 16 h of birth for infants. The first 10 mother-infant pairs were infused at a dose of 50 mg/kg, followed by 11 pairs at 200 mg/kg, and 10 pairs at 400 mg/kg. Study participants were followed for 30 months. RESULTS: Thirty-one women and 29 infants were infused with HIVIGLOB. The infusions were safe and well tolerated by the women and their infants at all doses. There were no significant changes in virologic or immunologic parameters after HIVIGLOB infusion. Pharmacokinetic properties of this product were similar to other immune globulin products with a median half-life of 28 days in women and 30 days in infants. CONCLUSION: An HIV immune globulin product derived from HIV infected Ugandan donors is safe, well tolerated, and has pharmacokinetic properties consistent with other immunoglobulin products. Data suggest that a 400 mg/kg dose of HIVIGLOB would be the most appropriate dose for a subsequent efficacy trial of HIVIGLOB for the prevention of mother to child HIV transmission.

Insecticide-treated bednet use, anaemia, and malaria parasitaemia in Blantyre District, Malawi.

OBJECTIVE: To evaluate the use of insecticide-treated bednets and the effectiveness of social marketing for their distribution. METHODS: Systematic cluster sample survey of 1080 households in 36 census enumeration areas across Blantyre district, Malawi, in February 2000. RESULTS: A total of 672 households had one or more children under 5. Bednet ownership was low (20.5% of households) overall, and significantly lower in rural areas than urban areas (6.4 vs. 29.8%, P=0.001). Only 3.3% of rural children under 5 had slept under a net the previous night, compared with 24.0% of urban children (P < 0.001). When asked why they did not own a net, nearly all (94.9%) caretakers in households without nets stated they had no money to buy them. In multivariate statistical models that controlled for the influence of house structure, urban vs. rural location, gender of the head of household, and the primary caretaker's education, rural children under 5 in households without nets experienced a statistically significant higher prevalence of malaria parasitaemia [RR (risk ratio) 4.9, 95% CI (confidence interval) 2.3-10.5] than children in households with at least one bednet. This was also true for urban children under 5 (RR 2.1, 95% CI 1.0-4.2, P=0.04). CONCLUSION: Social marketing approaches to promoting insecticide-treated nets in Blantyre District may have produced measurable health benefits for children in those households in which residents bought and used the products. Market-based approaches may take years to achieve high levels of coverage and may exaggerate inequities between urban and rural populations.