Effectiveness of an integrated multilevel early child development intervention on caregiver knowledge and behavior: a quasi-experimental evaluation of the Malezi program in Tanzania.

BACKGROUND: The quality of caregiving and the parent-child relationship is critical for early child development (ECD) and has been shown to be modifiable. This study evaluated an ECD project in Tanzania, assessing the effectiveness of radio messaging (RM) alone and a combined radio messaging/video job aids/ECD (RMV-ECD) intervention. METHODS: This two-arm pre-post evaluation study enrolled a cohort of caregivers of children 0-24 months in four districts of Tabora region, following them for 9 months. ECD radio messages were broadcast on popular stations at least 10 times/day reaching all study districts. In two districts, community health workers (CHW), trained in UNICEF's Care for Child Development package, used ECD videos in home- and facility-based sessions with caregivers. We used McNemar's testing (pre-post pairs) within intervention group to describe how the intervention was associated with change in five outcomes: ECD knowledge, early stimulation, father engagement, responsive care, and environment safety. Logistic regression was used to describe the relative benefits of the combined intervention package (RMV-ECD) compared to radio messaging (RM). RESULTS: In the RMV-ECD arm, all outcomes at endline except environment safety significantly improved after the intervention with the largest change seen in ECD knowledge (35.8% increase, p < .0001) and the smallest in father engagement (6.7%, p = .015). In the RM arm, ECD knowledge (5.7%, p = .031) and environment safety (18.1%, p = <.0001) improved. High measures of parenting stress were associated with lower likelihood of having good ECD knowledge (AOR 0.50, 95%CI: 0.35, 0.71), father engagement (AOR 0.72, 95%CI: 0.52, 0.99) and responsive care (AOR 0.31, 95%CI: 0.18, 0.54). CONCLUSIONS: An intervention that includes mass media, educational video content and CHWs who counsel caregivers in their homes and health facilities was associated with significant improvements in ECD parenting knowledge and behaviors but a relationship with responsive care could not be established. The less costly mass media-only intervention was associated with improved parenting knowledge and household environment safety. Parenting interventions targeting young children could be improved by incorporating more messaging and caregiver coaching in managing parental stress. TRIAL REGISTRATION: NCT05244161 (17/02/2022); retrospectively registered with the US National Institutes of Health ClinicalTrials.gov.

Tracing-corrected estimates of disengagement from HIV care and mortality among patients enrolling in HIV care without overt immunosuppression in Tanzania.

In the era of "test and treat", it is important to understand HIV care outcomes and their determinants in patients presenting to care with early-stage disease. We surveyed 924 adults newly enrolling in HIV care at four clinics in Tanzania before the adoption of universal treatment eligibility, and collected longitudinal clinical data. Participants who defaulted from care were tracked in the community. Cumulative incidence of disengagement from care and death was estimated using competing risk methods. By 12 months after enrollment, 18.2% of patients had disengaged from care and 6.9% had died. Factors associated with disengagement included male sex (adjusted subhazard ratio [aSHR] versus female = 1.75, 95% confidence interval [CI]: 1.06-2.89), provider-initiated HIV diagnosis (aSHR versus self-referred = 1.71, 95% CI: 1.03-2.86), ineligibility for antiretroviral treatment (ART) at enrollment (aSHR versus eligibility = 2.82, 95% CI: 1.84-4.32) and increased anticipated stigma score (aSHR = 1.04 per 5-point increase, 95% CI: 1.02-1.05). Higher life satisfaction score (aSHR = 0.97 per 5-point increase, 95% CI: 0.95-0.99) and having 1-2 close friends (aSHR versus none = 0.58, 95% CI: 0.47-0.71) were protective. The findings highlight the continued importance of social environment for HIV care outcomes and the potential of universal ART eligibility to reduce HIV care attrition.

Facilitators and barriers to antiretroviral therapy adherence among HIV-positive adolescents living in Tanzania.

BACKGROUND: Adolescents living with HIV face substandard outcomes along the continuum of care, including higher rates of poor adherence and virologic failure. Support groups have been identified as a method to improve adherence, but there is insufficient evidence regarding their effectiveness. This study seeks to examine the protective influences for and barriers to antiretroviral therapy (ART) adherence in HIV-positive adolescents living in Tanzania. METHODS: This is a qualitative study conducted in Tanzania from January to March 2018. The sample of adolescents aged 10-19 (n = 33) was purposefully selected based on age, gender, and support group attendance to capture a broad range of experiences. Participants completed an in-depth interview, covering topics such as retention in HIV services, support group experiences, and joys and challenges of adolescent life. Interviews were coded and themes related to ART adherence were identified and summarized. RESULTS: Support groups helped promote adherence by improving adolescents' knowledge and confidence. Participants associated joining support groups with an improvement in health. Almost every participant described the significant positive influence a treatment supporter had on adherence. Adolescents' daily schedules and emotional state served as a barrier to adherence. Furthermore, adherence was negatively impacted by participants' fear of accidental disclosure. CONCLUSION: Logistical and psychosocial factors can hinder adherence. Interventions that provide both education and psychosocial support, such as peer support groups, have the potential to improve health outcomes for this population, but may not address more persistent barriers to adherence rooted in lack of treatment support from family members or friends who have not been disclosed to, or lack of transportation funds/food security.

Willingness to use HIV self-test kits and willingness to pay among urban antenatal clients in Cote d'Ivoire and Tanzania: a cross-sectional study.

OBJECTIVES: To generate evidence on willingness to use HIV self-test kits and willingness to pay among antenatal care clients in public and private facilities in Cote d'Ivoire and Tanzania. METHODS: Cross-sectional survey data were collected from 414 clients recruited from 35 high-volume facilities in Cote d'Ivoire and from 385 clients in 33 high-volume facilities in Tanzania. Surveys covered willingness to use HIV self-test kits, prices clients were willing to pay, advantages and disadvantages and views on specific qualities of HIV self-tests. Market data on availability of proxy self-testing products (e.g. pregnancy and malaria tests) and attitudes of pharmacists towards HIV self-test kits were collected from 51 pharmacies in Cote d'Ivoire and 59 in Tanzania. RESULTS: Willingness to use HIV self-test kits was 65% in Cote d'Ivoire and 69% in Tanzania. Median ideal prices women would pay ranged from USD 1.77 in Cote d'Ivoire to USD 0.87 in Tanzania. Proxy self-test kits were available in pharmacies, and interest was high in stocking HIV self-test kits. CONCLUSIONS: Implications for national HIV self-test policy and planning include keeping prices low, providing psychological and HIV counselling, and ensuring linkage to HIV care and treatment services. Private pharmacies will play a key role in providing access to HIV self-test kits.

OBJECTIFS: Générer des données sur la volonté d'utiliser des kits d'auto-dépistage du VIH et la volonté de payer chez les clients des soins prénatals dans les établissements publics et privés en Côte d'Ivoire et en Tanzanie. MÉTHODES: Les données de l'enquête transversale ont été recueillies auprès de 414 patientes enrôlées dans 35 établissements de santé à volume élevé en Côte d'Ivoire et de 385 patientes dans 33 établissements de santé à volume élevé en Tanzanie. Les enquêtes ont porté sur la volonté d'utiliser des kits d'auto-dépistage du VIH, les prix que les clients étaient prêts à payer, les avantages et les inconvénients et les opinions sur les qualités spécifiques des auto-tests du VIH. Les données du marché sur la disponibilité des proxyse des produits d'auto-test (par exemple, les tests de grossesse et du paludisme) et les attitudes des pharmaciens envers les kits d'auto-test du VIH ont été collectées dans 51 pharmacies en Côte d'Ivoire et 59 en Tanzanie. RÉSULTATS: La volonté d'utiliser des kits d'auto-test VIH était de 65% en Côte d'Ivoire et de 69% en Tanzanie. Le prix médian idéal que les femmes paieraient allait de 1,77 USD en Côte d'Ivoire à 0,87 USD en Tanzanie. Des proxys de kits d'auto-test étaient disponibles dans les pharmacies et l'intérêt pour le stockage des kits d'auto-test du VIH était élevé. CONCLUSIONS: Les implications pour la politique et la planification nationales d'auto-test du VIH incluent le maintien de prix bas, la fourniture de conseils psychologiques et sur le VIH, et la garantie d'un lien avec les services de soins et de traitement du VIH. Les pharmacies privées joueront un rôle clé en donnant accès aux kits d'autotest du VIH.

Vulnerable at Each Step in the PMTCT Care Cascade: High Loss to Follow Up During Pregnancy and the Postpartum Period in Tanzania.

In 2013, Tanzania adopted the World Health Organization's Option B+ guidelines for prevention of mother-to-child transmission of HIV (PMTCT), whereby all HIV-infected pregnant women initiate lifelong antiretroviral therapy. This study examined retention in PMTCT across critical junctures in the care continuum. This was a retrospective study of patient-level data for a cohort of women enrolled in PMTCT during the first year of Option B+ in Tanzania. Retention in care was described across three periods: (1) the first month of antenatal care (ANC), (2) pregnancy, and (3) the postpartum period. Logistic regression was used to identify factors associated with loss to follow up (LTFU) during the first month of ANC. Survival analyses were used to identify factors associated with LTFU during pregnancy and the postpartum periods. 650 participants were included in the cohort; 262 (40.3%) were newly diagnosed with HIV. Two years after delivery, 383/650 (58.7%) were LTFU. Of the 383 LTFU, 73 (19.1%) were lost during the first month of ANC, 44 (11.5%) during pregnancy, and 266 (69.5%) after delivery. Being newly diagnosed with HIV predicted higher LTFU during the first month of ANC (aOR 1.76; 95% CI 1.06-2.94) and faster time to LTFU during the postpartum period (adjusted relative time, 0.68; 95% CI 0.51-0.89). High LTFU occurred across the PMTCT continuum, including immediately after enrollment into ANC and the postpartum period. Ongoing research is needed to encourage treatment uptake and sustained engagement after delivery.

Delivering Prevention Interventions to People Living with HIV in Clinical Care Settings: Results of a Cluster Randomized Trial in Kenya, Namibia, and Tanzania.

We conducted a group randomized trial to assess the feasibility and effectiveness of a multi-component, clinic-based HIV prevention intervention for HIV-positive patients attending clinical care in Namibia, Kenya, and Tanzania. Eighteen HIV care and treatment clinics (six per country) were randomly assigned to intervention or control arms. Approximately 200 sexually active clients from each clinic were enrolled and interviewed at baseline and 6- and 12-months post-intervention. Mixed model logistic regression with random effects for clinic and participant was used to assess the effectiveness of the intervention. Of 3522 HIV-positive patients enrolled, 3034 (86 %) completed a 12-month follow-up interview. Intervention participants were significantly more likely to report receiving provider-delivered messages on disclosure, partner testing, family planning, alcohol reduction, and consistent condom use compared to participants in comparison clinics. Participants in intervention clinics were less likely to report unprotected sex in the past 2 weeks (OR = 0.56, 95 % CI 0.32, 0.99) compared to participants in comparison clinics. In Tanzania, a higher percentage of participants in intervention clinics (17 %) reported using a highly effective method of contraception compared to participants in comparison clinics (10 %, OR = 2.25, 95 % CI 1.24, 4.10). This effect was not observed in Kenya or Namibia. HIV prevention services are feasible to implement as part of routine care and are associated with a self-reported decrease in unprotected sex. Further operational research is needed to identify strategies to address common operational challenges including staff turnover and large patient volumes.

Randomized controlled trial evaluating the effect of an interactive group counseling intervention for HIV-positive women on prenatal depression and disclosure of HIV status.

The objective of the study was to assess the effectiveness of group counseling, using a problem-solving therapy approach, on reducing depressive symptoms and increasing prenatal disclosure rates of HIV status among HIV-positive pregnant women living in Dar es Salaam, Tanzania. A randomized controlled trial was performed comparing a six-week structured nurse-midwife facilitated psychosocial support group with the standard of care. Sixty percent of women in the intervention group were depressed post-intervention, versus 73% in the control group [Relative Risk (RR) = 0.82, 95% confidence interval (CI): 0.67-1.01, p=0.066]. HIV disclosure rates did not differ across the two study arms. However, among those women who disclosed, there was a significantly higher level of overall personal satisfaction with the response to disclosure from family and friends among women in the treatment (88%) compared to the control group (62%; p=0.004). The results indicate reductions in the level of depressive symptoms comparable with major depressive disorder (MDD) for HIV-positive pregnant women participating in a group counseling intervention. Although the psychosocial group counseling did not significantly increase disclosure rates, an improvement in the level of personal satisfaction resulting from disclosure was associated with the intervention. This suggests that the counseling sessions have likely reduced the burden of depression and helped clients better manage partner reactions to disclosure. Public agencies and non-governmental organizations working in Tanzania and similar settings should consider offering structured psychosocial support groups to HIV-positive pregnant women to prevent poor mental health outcomes, promote early childhood development, and potentially impact HIV-related disease outcomes in the long term.

Reviewing progress: 7 year trends in characteristics of adults and children enrolled at HIV care and treatment clinics in the United Republic of Tanzania.

BACKGROUND: To evaluate the on-going scale-up of HIV programs, we assessed trends in patient characteristics at enrolment and ART initiation over 7 years of implementation. METHODS: Data were from Optimal Models, a prospective open cohort study of HIV-infected (HIV+) adults (≥15 years) and children (<15 years) enrolled from January 2005 to December 2011 at 44 HIV clinics in 3 regions of mainland Tanzania (Kagera, Kigoma, Pwani) and Zanzibar. Comparative statistics for trends in characteristics of patients enrolled in 2005-2007, 2008-2009 and 2010-2011 were examined. RESULTS: Overall 62,801 HIV + patients were enrolled: 58,102(92.5%) adults, (66.5% female); 4,699(7.5%) children.Among adults, pregnant women enrolment increased: 6.8%, 2005-2007; 12.1%, 2008-2009; 17.2%, 2010-2011; as did entry into care from prevention of mother-to-child HIV transmission (PMTCT) programs: 6.6%, 2005-2007; 9.5%, 2008-2009; 12.6%, 2010-2011. WHO stage IV at enrolment declined: 27.1%, 2005-2007; 20.2%, 2008-2009; 11.1% 2010-2011. Of the 42.5% and 29.5% with CD4+ data at enrolment and ART initiation respectively, median CD4+ count increased: 210 cells/µL, 2005-2007; 262 cells/µL, 2008-2009; 266 cells/µL 2010-2011; but median CD4+ at ART initiation did not change (148 cells/µL overall). Stavudine initiation declined: 84.9%, 2005-2007; 43.1%, 2008-2009; 19.7%, 2010-2011.Among children, median age (years) at enrolment decreased from 6.1(IQR:2.7-10.0) in 2005-2007 to 4.8(IQR:1.9-8.6) in 2008-2009, and 4.1(IQR:1.5-8.1) in 2010-2011 and children <24 months increased from 18.5% to 26.1% and 31.5% respectively. Entry from PMTCT was 7.0%, 2005-2007; 10.7%, 2008-2009; 15.0%, 2010-2011. WHO stage IV at enrolment declined from 22.9%, 2005-2007, to 18.3%, 2008-2009 to 13.9%, 2010-2011. Proportion initiating stavudine was 39.8% 2005-2007; 39.5%, 2008-2009; 26.1%, 2010-2011. Median age at ART initiation also declined significantly. CONCLUSIONS: Over time, the proportion of pregnant women and of adults and children enrolled from PMTCT programs increased. There was a decline in adults and children with advanced HIV disease at enrolment and initiation of stavudine. Pediatric age at enrolment and ART initiation declined. Results suggest HIV program maturation from an emergency response.

Improvement of community health worker counseling skills through early childhood development (ECD) videos, supervision and mentorship: A mixed methods pre-post evaluation from Tanzania.

BACKGROUND: Community health workers (CHWs) play significant roles in improving health practices in under- resourced communities. This study evaluated an early childhood development (ECD) project in Tanzania assessing the effect of mobile video use, supervision and mentorship to improve quality of CHW counseling skills. METHODS: CHWs participating in the Malezi Project in Tabora Region were enrolled in a mixed methods pre-post evaluation. CHWs previously trained in UNICEF's Care for Child Development package were further trained in counselling caregivers on nurturing care and father engagement using videos. Health providers were trained to provide ECD-focused supervision/mentorship of CHWs in facilities and during home visits. At baseline and endline, CHWs completed interviews and trained study staff observed and scored CHW counseling sessions using a structured checklist which were reduced into six dimensions through principal component analysis: introduce, educate, ask, plan/problem solve, interact/encourage, and responsive care. Twenty-five in-depth interviews were completed with caregivers and four focus group discussions with CHWs were conducted. RESULTS: Almost all (n = 107; 95%) 119 enrolled CHWs completed the expected eight observations (n = 471 baseline; n = 453 endline). At endline, more CHWs reported having one-on-one meetings with their supervisors (51% increasing to 75%; p < .0002) and that supervisors accompanied them to households for mentoring (60% increasing to 89%; p < .0001). We observed a shift in CHW counselling skills in clinic and home sessions. Scores in the categories of introduce, plan/problem solve, and interact/encourage significantly improved between baseline and endline; scores for ask and educate remained unchanged or decreased at both timepoints. Two-thirds of caregivers interviewed reported that father's involvement with their child increased due to CHW visits. Male participation increased in home observation sessions from 5.6% at baseline to 17.6% at endline (p < .0001). CONCLUSION: Use of videos, supervision, and mentorship were associated with CHW performance improvements in providing nurturing care counselling and in father engagement, especially in home settings.

Adolescent support club attendance and self-efficacy associated with HIV treatment outcomes in Tanzania.

HIV treatment outcomes may be improved by ameliorating psychosocial challenges adolescents living with HIV (ALHIV) face. This analysis describes participation in existing facility-based adolescent clubs and the associations between club attendance, adolescent well-being and HIV treatment outcomes. Data were collected through interviews with a sub-sample of adolescents age 10-19 years and medical record abstraction of all adolescents attending HIV services at seven clinics in Tanzania. Independent variables included adolescent club attendance, self-esteem, self-efficacy, mental distress, social capital and other health utilization or HIV experience characteristics. Study outcomes included visit adherence, viral suppression (<1000 cp/ml), and retention. Of 645 adolescents attending HIV services, 75% attended clubs at least once with a median of eight club sessions attended over a two-year period. Mental distress was prevalent, with 67% of the adolescents scoring above a recognized cut-off of ≥5. Adolescents who attended 10 or more clubs, compared to those not attending any clubs over a two-year period were at an almost three-fold increased odds of having good visit adherence (odds ratio [OR] 2.72, 95% confidence interval [CI]: 1.25, 5.94). Club attendance was also associated with sustained retention in the following year: adolescents who attended some clubs (1-9) had three-times the odds of being retained (OR 3.01; 95%CI: 1.86, 4.87) while those who attended 10+ had over seven-times the odds (OR 7.29; 95%CI: 4.34, 12.22). Among the 154 adolescents who were interviewed, being in the top self-efficacy tertile was positively associated with viral suppression (OR 3.04, 95%CI: 1.08, 8.60) and retention (OR 4.44, 95%CI: 1.19, 17.40). Attending the HIV clinic with a guardian/treatment supporter (OR 3.29, 95%CI: 1.17, 9.22) was also associated with viral suppression. Self-efficacy, social capital and treatment support are associated with better health outcomes among adolescents. However, many ALHIV either never attended or did not regularly attend clubs.

HIV risk screening and HIV testing among orphans and vulnerable children in community settings in Tanzania: Acceptability and fidelity to lay-cadre administration of the screening tool.

INTRODUCTION: HIV risk screening tool validation studies have not typically included process evaluations to understand tool implementation. The study aim was to assess the fidelity to which an HIV risk screening tool was administered by lay workers and acceptability of delivering home-based screening coupled with HIV testing to beneficiaries in an orphans and vulnerable children (OVC) program. METHODS: This cross-sectional study was conducted March-April 2019 in two regions of Tanzania. Community case workers (CCW) were observed conducting screenings with OVC 2-19 years and participated in focus group discussions. Research staff used structured observation checklists to capture if screening questions were asked or reworded by CCW. In-depth interviews were conducted with older adolescents and caregivers in their homes following screening and testing. A composite score was developed for the checklist. Qualitative data were thematically analyzed to address screening and testing perceptions and experiences. RESULTS: CCW (n = 32) participated in 166 observations. Commonly skipped items were malnutrition (34% of all observed screenings) and sexual activity and pregnancy (20% and 45% of screenings for adolescents only). Items frequently re-worded included child abuse (22%) and malnutrition (15%). CCW had an average composite observation score of 42/50. CCW in focus groups (n = 34) found the screening process acceptable. However, they described rewording some questions viewed as harsh or socially inappropriate to ask. Overall, adolescent beneficiaries (n = 17) and caregivers (n = 25) were satisfied with home-based screening and testing and reported no negative consequences. Learning one's HIV negative status was seen as an opportunity to discuss or recommit to healthy behaviors. While respondents identified multiple benefits of home testing, they noted the potential for privacy breaches in household settings. CONCLUSIONS: We found sub-optimal fidelity to the administration of the screening tool by CCW in home environments to children and adolescents enrolled in an OVC program. Improvements to questions and their delivery and ongoing mentorship could strengthen tool performance and HIV case finding using a targeted testing approach. Overall, home-based HIV risk screening and testing were acceptable to beneficiaries and CCW, could improve testing uptake, and serve as a platform to promote healthy behaviors for those with limited health system interactions.

Balancing HIV testing efficiency with HIV case-identification among children and adolescents (2-19 years) using an HIV risk screening approach in Tanzania.

To optimize HIV testing resources, programs are moving away from universal testing strategies toward a risk-based screening approach to testing children/adolescents, but there is little consensus around what defines an optimal risk screening tool. This study aimed to validate a 12-item risk screening tool among children and adolescents and provide suggested fewer-item tool options for screening both facility out-patient and community populations by age strata (<10 and ≥10 years). Children/adolescents (2-19 years) with unknown HIV status were recruited from a community-based vulnerable children program and health facilities in 5 regions of Tanzania in 2019. Lay workers administered the screening questions to caregivers/adolescents; nurses enrolled those eligible for the study and tested all participants for HIV. For each screening item, we estimated sensitivity, specificity, positive predictive value and negative predictive value and associated 95% confidence intervals (CI). We generated a score based on the count of items with a positive risk response and fit a receiver operating characteristic curve to determine a cut-off score. Sensitivity, specificity, positive predictive value (PPV; yield) and number needed to test to detect an HIV-positive child (NNT) were estimated for various tool options by age group. We enrolled 21,008 children and adolescents. The proportion of undiagnosed HIV-positive children was low (n = 76; 0.36%; CI:0.29,0.45%). A screening algorithm based on reporting at least one or more items on the 10 to 12-item tool had sensitivity 89.2% (CI:79.1,95.6), specificity 37.5% (CI:36.8,38.2), positive predictive value 0.5% (CI:0.4,0.6) and NNT = 211. An algorithm based on at least two or more items resulted in lower sensitivity (64.6%), improved specificity (69.1%), PPV (0.7%) and NNT = 145. A shorter tool derived from the 10 to 12-item screening tool with a score of "1" or more on the following items: relative died, ever hospitalized, cough, family member with HIV, and sexually active if 10-19 years performed optimally with 85.3% (CI:74.6,92.7) sensitivity, 44.2% (CI:43.5,44.9) specificity, 0.5% (CI:0.4,0.7) PPV and NNT = 193. We propose that different short-tool options (3-5 items) can achieve an optimal balance between reduced HIV testing costs (lower NNT) with acceptable sensitivity. In low prevalence settings, changes in yield may be negligible and NNT may remain high even for an effective tool.

Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials.

BACKGROUND: UNICEF/WHO recommends that infants born to HIV-infected mothers who do not have access to acceptable, feasible, affordable, sustainable, and safe replacement feeding should be exclusively breastfed for at least 6 months. The aim of three trials in Ethiopia, India, and Uganda was to assess whether daily nevirapine given to breastfed infants through 6 weeks of age can decrease HIV transmission via breastfeeding. METHODS: HIV-infected women breastfeeding their infants were eligible for participation. Participants were randomly assigned to receive either single-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborns after birth) or 6 week extended-dose nevirapine (nevirapine 200 mg to women in labour and nevirapine 2 mg/kg to newborn babies after birth plus nevirapine 5 mg daily from days 8-42 for the infant). The randomisation sequences were generated by computer at a central data coordinating centre. The primary endpoint was HIV infection at 6 months of age in infants who were HIV PCR negative at birth. Analyses were by modified intention to treat, excluding infants with missing specimens and those with indeterminate or confirmed HIV infection at birth. These studies are registered with ClinicalTrials.gov, numbers NCT00074399, NCT00061321, and NCT00639938. FINDINGS: 2024 liveborn infants randomised in the study had at least one specimen tested before 6 months of age (1047 infants in the single-dose group and 977 infants in the extended-dose group). The modified intention-to-treat population included 986 infants in the single-dose group and 901 in the extended-dose group. At 6 months, 87 children in the single-dose group and 62 in the extended-dose group were infected with HIV (relative risk 0.80, 95% CI 0.58-1.10; p=0.16). At 6 weeks of age, 54 children in the single-dose group and 25 in the extended-dose group were HIV positive (0.54, 0.34-0.85; p=0.009). 393 infants in the single-dose group and 346 in the extended-dose group experienced grade 3 or 4 serious adverse events during the study (p=0.54). INTERPRETATION: Although a 6-week regimen of daily nevirapine might be associated with a reduction in the risk of HIV transmission at 6 weeks of age, the lack of a significant reduction in the primary endpoint-risk of HIV transmission at 6 months-suggests that a longer course of daily infant nevirapine to prevent HIV transmission via breast milk might be more effective where access to affordable and safe replacement feeding is not yet available and where the risks of replacement feeding are high. FUNDING: US National Institutes of Health; US National Institute of Allergy and Infectious Diseases; Fogarty International Center.

Increased utilisation of PEPFAR-supported laboratory services by non-HIV patents in Tanzania.

BACKGROUND: It is unknown to what extent the non-HIV population utilises laboratories supported by the President's Emergency Plan for AIDS Relief (PEPFAR). OBJECTIVES: We aimed to describe the number and proportion of laboratory tests performed in 2009 and 2011 for patients referred from HIV and non-HIV services (NHSs) in a convenience sample collected from 127 laboratories supported by PEPFAR in Tanzania. We then compared changes in the proportions of tests performed for patients referred from NHSs in 2009 vs 2011. METHODS: Haematology, chemistry, tuberculosis and syphilis test data were collected from available laboratory registers. Referral sources, including HIV services, NHSs, or lack of a documented referral source, were recorded. A generalised linear mixed model reported the odds that a test was from a NHS. RESULTS: A total of 94 132 tests from 94 laboratories in 2009 and 157 343 tests from 101 laboratories in 2011 were recorded. Half of all tests lacked a documented referral source. Tests from NHSs constituted 42% (66 084) of all tests in 2011, compared with 31% (29 181) in 2009. A test in 2011 was twice as likely to have been referred from a NHS as in 2009 (adjusted odds ratio: 2.0 [95% confidence interval: 2.0-2.1]). CONCLUSION: Between 2009 and 2011, the number and proportion of tests from NHSs increased across all types of test. This finding may reflect increased documentation of NHS referrals or that the laboratory scale-up originally intended to service the HIV-positive population in Tanzania may be associated with a 'spillover effect' amongst the general population.

Trial of zinc supplements in relation to pregnancy outcomes, hematologic indicators, and T cell counts among HIV-1-infected women in Tanzania.

BACKGROUND: In observational studies, the zinc status of HIV-infected persons has been associated with both positive and adverse clinical outcomes. Such endpoints may affect the risk of adverse birth outcomes among HIV-infected women. OBJECTIVE: We examined the effects of zinc supplements on birth outcomes, hematologic indicators, and counts of T lymphocyte subsets among 400 HIV-infected pregnant women. DESIGN: Eligible women between 12 and 27 wk of gestation were randomly assigned to daily oral supplementation with either 25 mg Zn or placebo between recruitment and 6 wk after delivery. All women received iron, folic acid, and multivitamin supplements irrespective of the experimental assignment. RESULTS: We observed no significant differences in birth weight, duration of gestation, or fetal and neonatal mortality between women in the zinc and placebo groups. Hemoglobin concentrations increased between baseline and 6 wk postpartum in both groups. However, the rise in hemoglobin over this period was significantly lower (P = 0.03) in the zinc group (x +/- SD: 11.5 +/- 17.9 g/L) than in the placebo group (15.2 +/- 18.6 g/L). Similarly, the changes in red blood cell count and in packed cell volume over the same period were significantly lower in the zinc group (P < 0.01 and P = 0.01, respectively). Zinc had no effect on CD4(+), CD8(+), or CD3(+) cell counts during the follow-up period. CONCLUSION: Because of the lack of beneficial effects of zinc on adverse pregnancy outcomes and the likelihood of negative effects on hemoglobin concentrations, no compelling evidence exists to support the addition of zinc to prenatal supplements intended for pregnant HIV-infected women.

Implementation of antiretroviral therapy guidelines for under-five children in Tanzania: translating recommendations into practice.

INTRODUCTION: Paediatric antiretroviral therapy (ART) guidelines have been updated several times in recent years. We assessed implementation of ART guidelines among under-five children to inform the transition to universal paediatric ART in Tanzania. METHODS: We conducted a retrospective cohort analysis of infants (0 to 11 months) and children (12 to 59 months) enrolled between 2010 and 2012 using routinely collected data. Infants and children were initiated on ART according to the 2008 World Health Organization (WHO) recommendations/2009 Tanzania guidelines (universal ART for infants). Cumulative ART initiation incidence and correlates of ART initiation were examined using competing risk methods accounting for attrition (death or loss to follow-up). Kaplan-Meier methods and Cox regression models were used to examine attrition on ART and its correlates. RESULTS: A total of 1679 children were enrolled at 69 clinics: 469 (28%) infants and 1210 (74%) children. Infant cumulative ART initiation incidence was 59.6, 71.3 and 78.0% at one, three and six months of follow-up. Infants were more likely to start ART if enrolled in 2012 [adjusted sub-hazard ratio (AsHR)=2.2, 95% confidence interval (CI): 1.7 to 2.8] or 2011 (AsHR=1.8, 95% CI: 1.4 to 2.3) compared to 2010; they were more likely to start ART from prevention of mother-to-child HIV transmission (AsHR=1.6, 95% CI: 1.3 to 2.1) and inpatient wards (AsHR=1.5, 95% CI: 1.2 to 2.0) versus being enrolled from voluntary counselling and testing centres. Attrition at 12 months on ART was 33.9% and was more likely among infants with WHO Stage 4 [adjusted hazard ratio (AHR)=3.1. 95% CI: 1.8 to 5.2] and severe malnutrition (AHR=1.4, 95% CI: 1.0 to 1.9).Among 599 children eligible for ART at enrollment, cumulative ART initiation incidence was 51.8, 68.6 and 76.1% at one, three, and six months. Children were more likely to start ART if enrolled in 2012 (AsHR=1.8, 95% CI: 1.4 to 2.3) or 2011 (AsHR=1.5, 95% CI: 1.2 to 1.8) compared to 2010; they were more likely to start ART at primary health facilities (AsHR=1.5, 95% CI: 1.1 to 2.0) and less likely at urban facilities (AsHR=0.6, 95% CI: 0.5 to 0.9) and facilities without CD4 testing on site (AsHR=0.7, 95% CI: 0.5 to 0.9). Attrition at 12 months on ART was 23.1% and was more likely with severe malnutrition (AHR=1.8, 95% CI: 1.1 to 3.0), WHO Stage 4 (AHR=3.0, 95% CI: 1.0 to 8.5) and outpatient enrolees (AHR=1.7, 95% CI: 1.1 to 2.7). CONCLUSIONS: Our findings suggest the gradual adoption of guidelines over calendar time. Interventions to expedite ART initiation and support retention on ART are needed.

Pregnancy desire and dual method contraceptive use among people living with HIV attending clinical care in Kenya, Namibia and Tanzania.

AIM: To describe factors associated with pregnancy desire and dual method use among people living with HIV in clinical care in sub-Saharan Africa. DESIGN: Sexually active HIV-positive adults were enrolled in 18 HIV clinics in Kenya, Namibia and Tanzania. Demographic, clinical and reproductive health data were captured by interview and medical record abstraction. Correlates of desiring a pregnancy within the next 6 months, and dual method use [defined as consistent condom use together with a highly effective method of contraception (hormonal, intrauterine device (IUD), permanent)], among those not desiring pregnancy, were identified using logistic regression. RESULTS: Among 3375 participants (median age 37 years, 42% male, 64% on antiretroviral treatment), 565 (17%) desired a pregnancy within the next 6 months. Of those with no short-term fertility desire (n=2542), 686 (27%) reported dual method use, 250 (10%) highly effective contraceptive use only, 1332 (52%) condom use only, and 274 (11%) no protection. Respondents were more likely to desire a pregnancy if they were from Namibia and Tanzania, male, had a primary education, were married/cohabitating, and had fewer children. Factors associated with increased likelihood of dual method use included being female, being comfortable asking a partner to use a condom, and communication with a health care provider about family planning. Participants who perceived that their partner wanted a pregnancy were less likely to report dual method use. CONCLUSIONS: There was low dual method use and low use of highly effective contraception. Contraceptive protection was predominantly through condom-only use. These findings demonstrate the importance of integrating reproductive health services into routine HIV care.

Randomized trial of vitamin supplements in relation to transmission of HIV-1 through breastfeeding and early child mortality.

BACKGROUND: HIV-1 transmission through breastfeeding is a global problem and has been associated with poor maternal micronutrient status. METHODS: A total of 1078 HIV-infected pregnant women from Tanzania were randomly assigned to vitamin A or multivitamins excluding A from approximately 20 weeks' gestation and throughout lactation. RESULTS: Multivitamins excluding A had no effect on the total risk of HIV-1 transmission (RR 1.04, 95% CI 0.82-1.32, P= 0.76). Vitamin A increased the risk of transmission (RR 1.38, 95% CI 1.09-1.76, P = 0.009). Multivitamins were associated with non-statistically significant reductions in transmission through breastfeeding, and mortality by 24 months among those alive and not infected at 6 weeks. Multivitamins significantly reduced breastfeeding transmission in infants of mothers with low baseline lymphocyte counts (RR 0.37; 95% CI 0.16-0.85, P = 0.02) compared with infants of mothers with higher counts (RR 0.99, 95% CI 0.68-1.45, P = 0.97; -for-interaction 0.03). Multivitamins also protected against transmission among mothers with a high erythrocyte sedimentation rate (P-for-interaction 0.06), low hemoglobin (P-for-interaction 0.06), and low birthweight babies (P-for-interaction 0.04). Multivitamins reduced death and prolonged HIV-free survival significantly among children born to women with low maternal immunological or nutritional status. Vitamin A alone increased breastfeeding transmission but had no effect on mortality by 24 months. CONCLUSION: Vitamin A increased the risk of HIV-1 transmission. Multivitamin (B, C, and E) supplementation of breastfeeding mothers reduced child mortality and HIV-1 transmission through breastfeeding among immunologically and nutritionally compromised women. The provision of these supplements to HIV-infected lactating women should be considered.

Effect of prenatal vitamin supplementation on lower-genital levels of HIV type 1 and interleukin type 1 beta at 36 weeks of gestation.

Micronutrient status has been associated with shedding of human immunodeficiency virus type 1 (HIV-1) in the lower-genital tract in observational studies. We examined the effect of vitamin supplements on genital HIV-1 shedding and interleukin-1 beta (IL-1 beta ), a cytokine marker of vaginal inflammation and promotion of HIV-1 infection. Consenting HIV-1-infected pregnant women were randomized to receive daily supplementation with vitamin A and/or multivitamins B-complex, C, and E with use of a factorial design. Cervicovaginal lavage (CVL) specimens were obtained shortly before delivery. Significantly more women who received vitamin A had detectable levels of HIV-1 in CVL (74.8%), compared with those who did not receive vitamin A (65.1%) (P=.04, by multivariate analysis). Multivitamin B-complex, C, and E had no effect on the risk of viral shedding. Our results raise concern about the use of vitamin A supplements by HIV-1-infected women. Use of prenatal multivitamin supplements (including vitamins B-complex, C, and E) should be continued despite the lack of effect on HIV-1 transmission because of previously reported positive effects on maternal health and pregnancy outcomes.

Effect of providing vitamin supplements to human immunodeficiency virus-infected, lactating mothers on the child's morbidity and CD4+ cell counts.

A total of 1078 human immunodeficiency virus (HIV) type 1-infected women from Tanzania were randomized in a placebo-controlled trial using a factorial design to examine the effects of supplementation with vitamin A (preformed vitamin A and beta carotene) and/or multivitamins (vitamins B, C, and E). Supplements were given during pregnancy and lactation. Children of women in the multivitamin arms had a significantly lower risk of diarrhea than did those in the no-multivitamin arm (P=.03). The mean CD4+ cell count was 151 cells/microL higher among children in the multivitamin arms than among those in the no-multivitamin arm (P=.0006). HIV-positive children experienced a benefit apparently similar to that in HIV-negative children (P=.34, by test for interaction). Maternal receipt of vitamin A significantly reduced the risk that the child would have cough with a rapid respiratory rate, a proxy for pneumonia (P=.03), but receipt of vitamin A had no effect on diarrhea or CD4+ cell count. Provision of multivitamin supplements (including those with vitamins B, C, and E) to HIV-infected, lactating women may be a low-cost intervention to improve their children's health.