Antimalarial procurement in private-sector pharmaceutical outlets: decision-making complexities and implications for medicine quality in Tanzania.

Poor-quality medicines are a major threat to healthcare provision in low-income countries. The problem exacerbates disease vulnerabilities of already disadvantaged populations including children, women, and the elderly. However, while the higher-level structural drivers of this problem are well established, little is known about decision-making lower down pharmaceutical supply chains, and whether this might produce vulnerabilities for medicine quality. We conducted a mixed-methods study to explore retailer-supplier interactions and decision-making dynamics for antimalarial medicines in three regions of Tanzania: Tabora, Dodoma and Mbeya. A survey questionnaire was administered to 118 small scale-and mid-range retailers in urban and rural districts of the regions. We then conducted 12 in-depth interviews with staff and owners of medicine outlets in 2 districts of Tabora region to explore further the decision-making dynamics. Results show that private-sector retailers are driven first and foremost by business and economic practicalities when choosing a medicine supplier, prioritising low purchase price, free delivery, and availability of credit. Many also rely on suppliers with whom they have personal connections, developed either within or outside the business context. Medicine quality comes far lower down the list of priorities. These findings are perhaps not surprising in a context where businesses serving low-income customers are operating on very small margins. However, when price and personal connection eclipse any other considerations, there is a risk that poor-quality medicines may find their way into supply chains, especially in countries where regulatory capacity is limited, and pharmaceutical supply chains are complex and opaque.

Effect of herpes simplex suppression on incidence of HIV among women in Tanzania.

BACKGROUND: Infection with herpes simplex virus type 2 (HSV-2) is associated with an increased risk of acquiring infection with the human immunodeficiency virus (HIV). This study tested the hypothesis that HSV-2 suppressive therapy reduces the risk of HIV acquisition. METHODS: Female workers at recreational facilities in northwestern Tanzania who were 16 to 35 years of age were interviewed and underwent serologic testing for HIV and HSV-2. We enrolled female workers who were HIV-seronegative and HSV-2-seropositive in a randomized, double-blind, placebo-controlled trial of suppressive treatment with acyclovir (400 mg twice daily). Participants attended mobile clinics every 3 months for a follow-up period of 12 to 30 months, depending on enrollment date. The primary outcome was the incidence of infection with HIV. We used a modified intention-to-treat analysis; data for participants who became pregnant were censored. Adherence to treatment was estimated by a tablet count at each visit. RESULTS: A total of 821 participants were randomly assigned to receive acyclovir (400 participants) or placebo (421 participants); 679 (83%) completed follow-up. Mean follow-up for the acyclovir and placebo groups was 1.52 and 1.62 years, respectively. The incidence of HIV infection was 4.27 per 100 person-years (27 participants in the acyclovir group and 28 in the placebo group), and there was no overall effect of acyclovir on the incidence of HIV (rate ratio for the acyclovir group, 1.08; 95% confidence interval, 0.64 to 1.83). The estimated median adherence was 90%. Genital HSV was detected in a similar proportion of participants in the two study groups at 6, 12, and 24 months. No serious adverse events were attributable to treatment with acyclovir. CONCLUSIONS: These data show no evidence that acyclovir (400 mg twice daily) as HSV suppressive therapy decreases the incidence of infection with HIV. (Current Controlled Trials number, ISRCTN35385041 [controlled-trials.com].).

Improving surgical quality in low-income and middle-income countries: why do some health facilities perform better than others?

BACKGROUND: Evidence on heterogeneity in outcomes of surgical quality interventions in low-income and middle-income countries is limited. We explored factors driving performance in the Safe Surgery 2020 intervention in Tanzania's Lake Zone to distil implementation lessons for low-resource settings. METHODS: We identified higher (n=3) and lower (n=3) performers from quantitative data on improvement from 14 safety and teamwork and communication indicators at 0 and 12 months from 10 intervention facilities, using a positive deviance framework. From 72 key informant interviews with surgical providers across facilities at 1, 6 and 12 months, we used a grounded theory approach to identify practices of higher and lower performers. RESULTS: Performance experiences of higher and lower performers differed on the following themes: (1) preintervention context, (2) engagement with Safe Surgery 2020 interventions, (3) teamwork and communication orientation, (4) collective learning orientation, (5) role of leadership, and (6) perceived impact of Safe Surgery 2020 and beyond. Higher performers had a culture of teamwork which helped them capitalise on Safe Surgery 2020 to improve surgical ecosystems holistically on safety practices, teamwork and communication. Lower performers prioritised overhauling safety practices and began considering organisational cultural changes much later. Thus, while also improving, lower performers prioritised different goals and trailed higher performers on the change continuum. CONCLUSION: Future interventions should be tailored to facility context and invest in strengthening teamwork, communication and collective learning and facilitate leadership engagement to build a receptive climate for successful implementation of safe surgery interventions.

The need for further integration of services to prevent mother-to-child transmission of HIV and syphilis in Mwanza City, Tanzania.

OBJECTIVE: To assess the operational integration of maternal HIV testing and syphilis screening in Mwanza, Tanzania. METHODS: Interviews were conducted with 76 health workers (HW) from three antenatal clinics (ANC) and three maternity wards in 2008-2009 and 1137 consecutive women admitted for delivery. Nine ANC health education sessions and client flow observations were observed. RESULTS: Only 25.0% of HWs reported they had received training in both prevention of mother-to-child transmission (PMTCT) and syphilis screening. HIV and syphilis tests were sometimes performed in different rooms and results recorded in separate registers with different formats and the results were not always given by the same person. At delivery, most women had been tested for both HIV (79.4%) and syphilis (88.1%) during pregnancy. Of those not tested antenatally for each infection, 70.1% were tested for HIV at delivery but none for syphilis. CONCLUSION: Integration of maternal HIV and syphilis screening was limited. Integrated care guidelines and related health worker training should address this gap.

Missed opportunities: poor linkage into ongoing care for HIV-positive pregnant women in Mwanza, Tanzania.

BACKGROUND: Global coverage of prevention of mother-to-child (PMTCT) services reached 53% in 2009. However the number of pregnant women who test positive for HIV in antenatal clinics and who link into long-term HIV care is not known in many resource-poor countries. We measured the proportion of HIV-positive pregnant women in Mwanza city, Tanzania, who completed the cascade of care from antenatal HIV diagnosis to assessment and engagement in care in adult HIV clinics. METHODS: Thirty antenatal and maternity ward health workers were interviewed about PMTCT activities. Nine antenatal HIV education sessions were observed. A prospective cohort of 403 HIV-positive women was enrolled by specially-trained clinicians and nurses on admission to delivery and followed for four months post-partum. Information was collected on referral and attendance at adult HIV clinics, eligibility for highly active antiretroviral therapy (HAART) and reasons for lack of attendance. RESULTS: Overall, 70% of PMTCT health workers referred HIV-positive pregnant women to the HIV clinic for assessment and care. Antenatal HIV education sessions did not cover on-going care for HIV-infected women. Of 310 cohort participants tested in pregnancy, 51% had received an HIV clinic referral pre-delivery. Only 32% of 244 women followed to four months post-partum had attended an HIV clinic and been assessed for HAART eligibility. Non-attendance for HIV care was independently associated with fewer antenatal visits, poor PMTCT prophylaxis compliance, non-disclosure of HIV status, and non-Sukuma ethnicity. CONCLUSION: Most women identified as HIV-positive during pregnancy were not assessed for HAART eligibility during pregnancy or in the first four months post-partum. Initiating HAART at the antenatal clinic, improved counselling and linkages to care between PMTCT and adult HIV treatment services and reducing stigma surrounding disclosure of HIV results would benefit on-going care of HIV-positive pregnant women.

Adverse birth outcomes in United Republic of Tanzania--impact and prevention of maternal risk factors.

OBJECTIVE: To determine risk factors for poor birth outcome and their population attributable fractions. METHODS: 1688 women who attended for antenatal care were recruited into a prospective study of the effectiveness of syphilis screening and treatment. All women were screened and treated for syphilis and other reproductive tract infections (RTIs) during pregnancy and followed to delivery to measure the incidence of stillbirth, intrauterine growth retardation (IUGR), low birth weight (LBW) and preterm live birth. FINDINGS: At delivery, 2.7% of 1536 women experienced a stillbirth, 12% of live births were preterm and 8% were LBW. Stillbirth was independently associated with a past history of stillbirth, short maternal stature and anaemia. LBW was associated with short maternal stature, ethnicity, occupation, gravidity and maternal malaria whereas preterm birth was associated with occupation, age of sexual debut, untreated bacterial vaginosis and maternal malaria. IUGR was associated with gravidity, maternal malaria, short stature, and delivering a female infant. In the women who had been screened and treated for syphilis, in between 20 and 34% of women with each outcome was estimated to be attributable to malaria, and 63% of stillbirths were estimated as being attributable to maternal anaemia. Screening and treatment of RTIs was effective and no association was seen between treated RTIs and adverse pregnancy outcomes. CONCLUSION: Maternal malaria and anaemia continue to be significant causes of adverse pregnancy outcome in sub-Saharan Africa. Providing reproductive health services that include treatment of RTIs and prevention of malaria and maternal anaemia to reduce adverse birth outcomes remains a priority.

Risk factors for herpes simplex virus type 2 and HIV among women at high risk in northwestern Tanzania: preparing for an HSV-2 intervention trial.

OBJECTIVES: To determine prevalence of and risk factors for herpes simplex virus type 2 (HSV-2) and HIV among women being screened for a randomized, controlled trial of HSV suppressive therapy in northwestern Tanzania. METHODS: Two thousand seven hundred nineteen female facility workers aged 16 to 35 were interviewed and underwent serological testing for HIV and HSV-2. Factors associated with HSV-2 and HIV in women aged 16 to 24 were examined using logistic regression to estimate odds ratios (OR) and 95% confidence intervals (CI). RESULTS: HSV-2 seroprevalence was 80%, and HIV seroprevalence was 30%. Among women aged 16 to 24, both infections were significantly and independently associated with older age, being a bar worker, working at a truck stop, and having more lifetime sexual partners. HSV-2 infection was also associated with lower socioeconomic status, increased alcohol intake, younger age at first sex, inconsistent condom use, and vaginal douching. There was a strong association between the 2 infections after adjustment for other factors (OR = 4.22, 95% CI: 2.6 to 6.9). CONCLUSIONS: Female facility workers in northwestern Tanzania are vulnerable to HSV-2 and HIV infections. Programs designed to increase safer sexual behavior and reduce alcohol use could be effective in reducing HSV-2 incidence and, in turn, HIV infection. This is a suitable population for an HSV suppressive therapy trial.

Microbicides development program, Tanzania-baseline characteristics of an occupational cohort and reattendance at 3 months.

OBJECTIVES: To determine baseline characteristics of an occupational cohort of women in Mwanza City, Tanzania, and factors associated with reattendance at 3 months, in preparation for a microbicide trial. STUDY DESIGN: One thousand five hundred seventy-three women aged 16-54 years working in food outlets and recreational facilities were enrolled, interviewed, and examined at community-based reproductive health clinics, provided specimens for HIV/STI and pregnancy testing, and attended 3 monthly clinical follow-up. RESULTS: Baseline prevalence of HIV was 25.5%; pregnancy 9.7%; herpes simplex virus type-2 74.6%; active syphilis 10.2%, bacterial vaginosis 52.6%; gonorrhea 5.5%; chlamydia 5.9%; and trichomoniasis 12.3%. Reattendance at 3 months was 74.1% and was higher in older women, less mobile women, and in those who received an HIV-negative result at enrollment. CONCLUSIONS: Baseline characteristics of this occupational group suggest their suitability for microbicide trials. A screening round, locally appropriate informed consent procedures, and effective community tracing may help reduce losses to follow-up in such settings.

Risk factors influencing HIV infection incidence in a rural African population: a nested case-control study.

BACKGROUND: Risk factors influencing the incidence of human immunodeficiency virus (HIV) infection were investigated in a case-control study nested within a community-randomized trial of treatment of syndromic sexually transmitted infections (STIs) in rural Tanzania. METHODS: Case patients were persons who became HIV positive, and control subjects were randomly selected from among persons who remained HIV negative. For each sex, we obtained adjusted odds ratios (ORs) and population-attributable fractions (PAFs) for biomedical and behavioral factors. RESULTS: We analyzed 92 case patients and 903 control subjects. In both sexes, the incidence of HIV infection was significantly higher in subjects with an HIV-positive spouse than in those with HIV-negative spouse (men: OR, 25.1; women: OR, 34.0). The incidence of HIV infection was significantly higher in those who became positive for herpes simplex virus type 2 (HSV-2) (men: OR, 5.60; women: OR, 4.76) and those who were HSV-2-positive at baseline (men: OR, 3.66; women: OR, 2.88) than in subjects who were HSV-2 negative. In women, living elsewhere (OR, 3.22) and never having given birth (OR, 4.27) were significant risk factors. After adjustment, the incidence of HIV infection was not significantly associated with a history of injections or STIs in either sex. CONCLUSION: HSV-2 infection was the most important risk factor for HIV infection, which highlights the need for HSV-2 interventions in HIV infection control, and there were particularly strong associations with recent HSV-2 seroconversion. The PAF associated with having an HIV-positive spouse was low, but this is likely to increase during the epidemic.

Asking semi-literate adolescents about sexual behaviour: the validity of assisted self-completion questionnaire (ASCQ) data in rural Tanzania.

OBJECTIVES: To develop and test a sexual behaviour survey method for semi-literate populations, combining the privacy of a self-completion questionnaire (SCQ) with the clarity of a face-to-face questionnaire (FFQ). METHODS: In 1998, 6079 Tanzanian primary school students (mean age 15.1 years) were surveyed using an innovative assisted self-completion questionnaire (ASCQ). The format of the questionnaire was simple, all responses were closed, and conceptually complex questions such as those involving ranking or multiple answers were avoided. The ASCQ was administered to groups of 20 by a research assistant who read questions and answers aloud in two languages so pupils could tick or write responses independently. A total of 4958 of respondents from the 1998 ASCQ Cohort also participated in a 1998 FFQ interview and, in 2000, 4424 again completed an ASCQ. RESULTS: In the 1998 ASCQ survey, 55.0% of males and 21.1% of females reported they had had vaginal intercourse, of whom 71.5% and 66.0%, respectively reported their first sexual relationship lasted for a week or less, and 49.5% and 59.6%, respectively reported they had had sex in the last 4 weeks. After adjustment for age, reported sex was associated with alcohol use in both males (OR = 1.57) and females (OR = 1.69), earning money for males (OR = 1.32) and not living with a mother for females (OR = 0.77). The vast majority of respondents did not appear to have difficulty completing the ASCQ, but 7.4% of 1998 respondents and 2.9% of 2000 respondents selected all first or all last answers in a section for which this was inconsistent. This bias was associated with female, less educated and more geographically remote respondents. Of those respondents who reported sex in the 1998 ASCQ survey, 32.1% reported fewer total partners in the 2000 ASCQ survey, 25.2% reported having had sex fewer times than originally reported, and 61.9% of those who reported having used a condom in 1998 reported never having used one in 2000. While the proportions reporting sex were very similar in the 1998 ASCQ and FFQ surveys, 37.9% of males and 59.2% of females reporting sex only did so on one of the two questionnaires. Higher proportions of respondents reported sensitive information in the ASCQ than the FFQ, although in some cases this may have related to answer order bias. CONCLUSION: The results suggest that an ASCQ may be useful in assessing sexual behaviour in African adolescents, particularly for older, male and/or educated respondents. However, triangulation with data from other surveys raises questions about the validity of self-reported sexual behaviour in general.

Syphilis in pregnancy in Tanzania. I. Impact of maternal syphilis on outcome of pregnancy.

To measure the impact of maternal syphilis on pregnancy outcome in the Mwanza Region of Tanzania, 380 previously unscreened pregnant women were recruited into a retrospective cohort at delivery and tested for syphilis. Stillbirth was observed in 18 (25%) of 73 women with high-titer active syphilis (i.e., women with a rapid plasma reagin titer > or = 1 :8 and a positive Treponema pallidum hemagglutination assay or indirect fluorescent treponemal antibody test result), compared with 3 (1%) of 233 uninfected women (risk ratio [RR], 18.1; P<.001). Women with high-titer active syphilis were also at the greatest risk of having low-birth-weight or preterm live births (RR, 3.0 and 6.1, respectively), compared with women with other serological stages of syphilis. Among unscreened women, 51% of stillbirths, 24% of preterm live births, and 17% of all adverse pregnancy outcomes were attributable to maternal syphilis. Syphilis continues to be a major cause of pregnancy loss and adverse pregnancy outcome among women who do not receive antenatal syphilis screening and treatment.

Syphilis in pregnancy in Tanzania. II. The effectiveness of antenatal syphilis screening and single-dose benzathine penicillin treatment for the prevention of adverse pregnancy outcomes.

Treatment for maternal syphilis with single-dose benzathine penicillin (2.4 million units intramuscularly) is being implemented in many parts of sub-Saharan Africa. To examine the effectiveness of this regimen, a prospective cohort of 1688 pregnant women was recruited in Tanzania. Birth outcomes were compared among women treated for high-titer (n=133; rapid plasma reagin [RPR] titer > or = 1:8 and Treponema pallidum hemagglutination assay [TPHA]/fluorescent treponemal antibody [FTA] positive) and low-titer (n=249; RPR titer <1:8 and TPHA/FTA positive) active syphilis and 950 uninfected women. Stillbirth or low-birth-weight live births were observed in 2.3% and 6.3%, respectively, of women treated for high-titer active syphilis and in 2.5% and 9.2%, respectively, of seronegative women. There was no increased risk for adverse pregnancy outcome for women treated for high-titer active syphilis (odds ratio [OR], 0.76; 95% confidence interval [CI], 0.4-1.4) or low-titer active syphilis (OR, 0.95; 95% CI, 0.6-1.5), compared with seronegative women. Single-dose treatment is effective in preventing adverse pregnancy outcomes attributable to maternal syphilis.