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BackgroundDespite the scale-up of ART and the rollout in Tanzania of dolutegravir, an integrase strand transfer inhibitor (INSTI), treatment success has not been fully realized. HIV drug resistance (HIVDR), including dolutegravir resistance, could be implicated in the notable suboptimal viral load (VL) suppression among HIV patients.ObjectivesTo determine the prevalence and patterns of acquired drug resistance mutations (DRMs) among children and adults in Tanzania.MethodsA national cross-sectional HIVDR survey was conducted among 866 children and 1173 adults. Genotyping was done on dried blood spot and/or plasma of participants with high HIV VL (≥1000 copies/mL). HIV genes (reverse transcriptase, protease and integrase) were amplified by PCR and directly sequenced. The Stanford HIVDR Database was used for HIVDR interpretation.ResultsHIVDR genotyping was performed on blood samples from 137 participants (92 children and 45 adults) with VL ≥ 1000 copies/mL. The overall prevalence of HIV DRMs was 71.5%, with DRMs present in 78.3% of children and 57.8% of adults. Importantly, 5.8% of participants had INSTI DRMs including major DRMs: Q148K, E138K, G118R, G140A, T66A and R263K. NNRTI, NRTI and PI DRMs were also detected in 62.8%, 44.5% and 8% of participants, respectively. All the participants with major INSTI DRMs harboured DRMs targeting NRTI backbone drugs.ConclusionsMore than 7 in 10 patients with high HIV viraemia in Tanzania have DRMs. The early emergence of dolutegravir resistance is of concern for the efficacy of the Tanzanian ART programme.

PurposeWe hypothesized that an intervention designed to create girl-friendly drug shops would increase access to sexual and reproductive health products and services among adolescent girls and young women (AGYW) (ages 15-24 years) in Tanzania.MethodsWe conducted a four-month randomized trial at 20 drug shops in Shinyanga, Tanzania from August-December 2019 to determine if the Malkia Klabu ("Queen Club") intervention increased AGYW patronage and the provision of HIV self-testing (HIVST), contraception, and health facility referrals to AGYW (primary outcomes). Drug shops were randomized 1:1 to the intervention or comparison arm. All shops were provided with OraQuick HIVST kits to give to AGYW for free. Intervention shops implemented Malkia Klabu, a loyalty program for AGYW created using human-centered design through which AGYW could also access free contraception. We compared outcomes in intention-to-treat analyses using shop observations and shopkeeper records.ResultsBy endline, shops implementing Malkia Klabu had higher AGYW patronage than comparison shops (rate ratio: 4.4; 95% confidence interval: 2.0, 9.8). Intervention shops distributed more HIVST kits (median per shop: 130.5 vs. 58.5, P= .02) and contraceptives (325.5 vs. 7.0, P < .01) to AGYW and provided more referrals for HIV, family planning, or pregnancy services combined (3.5 vs. 0.5, P= .02) than comparison shops.DiscussionThe Malkia Klabu intervention increased AGYW patronage and the provision of HIVST kits, contraception, and referrals to AGYW at drug shops, despite HIVST kits being freely available at all participating shops. Enhancing drug shops with girl-friendly services may be an effective strategy to reach AGYW with sexual and reproductive health services.

Mobile women are at risk of HIV infection in sub-Saharan Africa, although we lack evidence for HIV risk among women in mobile partnerships, especially in the context of household food insecurity, a growing concern in the region.Women aged 15-59 years with a cohabitating male partner who participated in population-based HIV impact assessment surveys in Eswatini, Lesotho, Namibia, Tanzania, Uganda, and Zambia.We evaluated the association between women's and their partner's mobility (being away from home for more than 1 month or staying elsewhere) and transactional sex (selling sex or receiving money or goods in exchange for sex). We examined associations for effect measure modification by food insecurity level in the household in the past month. We used survey-weighted logistic regression, pooled and by country, adjusting for individual, partner, and household-level variables.Among women with a cohabitating male partner, 8.0% reported transactional sex, ranging from 2.7% in Lesotho to 13.4% in Uganda. Women's mobility [aOR 1.35 (95% CI: 1.08 to 1.68)], but not their partner's mobility [aOR 0.91 (0.74-1.12)], was associated with transactional sex. Food insecurity was associated with transactional sex independent of mobility [aOR 1.29 (1.10-1.52)]. Among those who were food insecure, mobility was not associated with increased odds of transactional sex.Food insecurity and women's mobility each increased the odds of transactional sex. Because transactional sex is associated with HIV risk, prevention programs can address the needs of mobile and food-insecure women, including those in cohabitating relationships.

Cash transfers are increasingly used to motivate adherence to HIV care. However, evidence on cash transfers and intimate partner violence (IPV) is mixed and little is known about their safety for women living with HIV. We conducted in-depth interviews with women living with HIV who participated in a randomized trial providing 6 months of cash transfers (~$4.5 or $11 USD) conditional on HIV clinic attendance in Shinyanga, Tanzania to assess how receiving cash affects IPV and relationship dynamics. Eligible participants were 18–49 years, received cash transfers, and in a partnership at baseline. Data were analyzed in Dedoose using a combined inductive-deductive coding approach. 25 interviews were conducted between November 2019-February 2020. Women’s employment was found to be a source of household tension and violence. None of the participants reported physical or sexual IPV in relation to cash transfers, however, some women experienced controlling behaviors or emotional violence including accusations and withholding of money, particularly those who were unemployed. Cash transfers were predominantly used for small household expenses and were not viewed as being substantial enough to shift the financial dynamic or balance of power within relationships. Our findings suggest that small, short-term cash transfers do not increase physical or sexual IPV for women living with HIV however can exacerbate controlling behaviors or emotional violence. Modest incentives used as a behavioral nudge to improve health outcomes may affect women differently than employment or larger cash transfers. Nonetheless, consultations with beneficiaries should be prioritized to protect women from potential IPV risks.

Population-based biomarker surveys are the gold standard for estimating HIV prevalence but are susceptible to substantial non-participation (up to 30%). Analytical missing data methods, including inverse-probability weighting (IPW) and multiple imputation (MI), are biased when data are missing-not-at-random, for example when people living with HIV more frequently decline participation. Heckman-type selection models can, under certain assumptions, recover unbiased prevalence estimates in such scenarios.We pooled data from 142,706 participants aged 15-49 years from nationally representative cross-sectional Population-based HIV Impact Assessments in seven countries in sub-Saharan Africa, conducted between 2015 and 2018 in Tanzania, Uganda, Malawi, Zambia, Zimbabwe, Lesotho and Eswatini. We compared sex-stratified HIV prevalence estimates from unadjusted, IPW, MI and selection models, controlling for household and individual-level predictors of non-participation, and assessed the sensitivity of selection models to the copula function specifying the correlation between study participation and HIV status.In total, 84.1% of participants provided a blood sample to determine HIV serostatus (range: 76% in Malawi to 95% in Uganda). HIV prevalence estimates from selection models diverged from IPW and MI models by up to 5% in Lesotho, without substantial precision loss. In Tanzania, the IPW model yielded lower HIV prevalence estimates among males than the best-fitting copula selection model (3.8% vs. 7.9%).We demonstrate how HIV prevalence estimates from selection models can differ from those obtained under missing-at-random assumptions. Further benefits include exploration of plausible relationships between participation and outcome. While selection models require additional assumptions and careful specification, they are an important tool for triangulating prevalence estimates in surveys with substantial missing data due to non-participation.

Background Viral suppression is key to ending the HIV epidemic, yet only 58% of people living with HIV (PLHIV) in sub-Saharan Africa are suppressed. Cash transfers are an effective strategy to improve retention in care, but little is known about optimization of implementation; for example, designing effective programs that integrate into existing clinic workflows. We studied implementation of an mHealth system to deliver cash transfers to support retention. Methods We conducted a mixed-methods study assessing implementation of an mHealth cash transfer study. This was part of a larger, hybrid implementation-effectiveness randomized controlled trial evaluating cash transfers conditional on visit attendance for viral suppression among Tanzanian PLHIV initiating ART. An mHealth system using fingerprint identification and mobile payments was used to automatically disburse mobile money to eligible PLHIV. We used Proctor’s framework, assessing implementation of the mHealth system from the perspectives of PLHIV and clinicians. We analyzed mHealth system data and conducted surveys (n = 530) and in-depth interviews (n = 25) with PLHIV, clinic and pharmacy staff (n = 10), and structured clinic observations (n = 2293 visits). Results One thousand six hundred fifty-one cash transfers were delivered to 346 PLHIV in the cash arms, 78% through mobile money. Among those in the cash arms, 81% registered their mobile money account with the mHealth system by study end, signaling high adoption. While acceptability for fingerprinting and mobile payments was high among PLHIV, interviews revealed mixed views: some had privacy concerns while others felt the system was secure and accurate, and provided some legitimacy to the clinical visits. Pharmacists praised system efficiency, but concerns about duplicative recordkeeping and added work arose. Clinic staff voiced excitement for the system’s potential to bring the cash program to all patients and simplify workflows; yet concerns about multiple systems, staffing, and intermittent connectivity tempered enthusiasm, highlighting structural issues beyond program scope. Structured observations revealed a steep learning curve; repeat fingerprint scans and manual entry declined as the system improved. Conclusions Biometric identification and mobile payments were acceptable to most patients and staff. Fingerprinting encountered some feasibility limitations in the first months of testing; however, mobile payments were highly successful. Biometric identification and mobile payments may provide a scalable mechanism to improve patient tracking and efficiently implement financial incentives in low-resource settings. Trial registration Name of the registry: clinicaltrials.gov Trial registration number: NCT03351556 Date of registration: 11/24/2017 Checklists: StaRI (included with submission). Note CONSORT for cluster-randomized trials was used for the main trial but is not directly applicable to this manuscript.

Heavy load carrying of water, firewood, and sand/stones is a ubiquitous activity for women living in developing countries. Although the intra-abdominal pressure associated with heavy load carrying is hypothesized to increase the risk of pelvic organ prolapse (POP) among women, relevant epidemiologic data are lacking. We conducted a comparative study involving two exploratory cross-sectional studies among convenience samples of women carrying heavy loads, with different characteristics: (1) as part of their activities for daily living, in Shinyanga region, Tanzania; and (2) working as sand miners in Pokhara, Nepal. Women were categorized has having “low” or “high” load-carrying exposures based on the measured weights of the loads being carried at the time of the survey, as well as on self-reported duration and frequency of load carrying. A summary score for reproductive health discomfort suggestive of POP was generated using questions from the Pelvic Organ Prolapse Distress Inventory (POPDI-6). Women with higher load carrying exposures had on average higher reproductive health discomfort scores in both Tanzania (adjusted prevalence difference (PDa)=3.7; 95% CI: -3.8-11.3; p=0.33) and Nepal (PDa=9.3; 95% CI: -4.9-23.6; p=0.18). We identified trends suggestive of an association between increasing heavy load carrying exposures and symptoms of reproductive health discomfort. Our findings underscore the need for larger epidemiologic studies of the potential adverse reproductive health effects of heavy load carrying activities on women in developing countries.

Background: Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve HIV care and treatment outcomes, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based intervention to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone Region, Tanzania.Methods: We will conduct a type I hybrid implementation – effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with an mobile health technology (mHealth) system through measurement of implementation science constructs. Specifically, our team will expand the intervention to 32 clinics and enroll 1,984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome; and (b) evaluate the implementation challenges and successes at multiple levels (patient, provider, clinic).Discussion: This trial will provide evidence about not only the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.Trial Registration: Clinicaltrails.govRegistration Number: NCT04201353 Date of Registration: December 17th, 2019URL for Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04201353

BACKGROUND Early infant diagnosis (EID) of HIV and timely initiation of antiretroviral therapy reduces morbidity and mortality in HIV-infected infants and children. Although the WHO had a global target for 2018 that 90% of HIV-exposed infants (HEI) should be tested by the age of 8 weeks, by 2015 only half were being tested. This study describes trends and predictors for HIV first testing in HEI in Dar es Salaam, Tanzania, from 2014 to 2016. METHODS We conducted a cross-sectional study of HEI attending HIV services using secondary data collected at health facilities and collated at the national level. We estimated odds ratios and 95% confidence intervals for factors affecting uptake of HIV testing. RESULTS Of 12,117 HEI, the proportion tested for HIV by age 8 weeks increased from 53.2% in 2014 to 69.2% in 2016; 2.3% were HIV-positive. Replacement feeding (aOR=2.94, 95% CI 2.31 – 3.74) and receiving nevirapine prophylaxis (aOR=1.55, 95% CI 1.28-1.88) were predictors for EID testing uptake. HEI born to mothers with WHO stage II (aOR=0.53, 95% CI 0.41 – 0.67), stage III (aOR=0.64, 95% CI; 0.52 – 0.79) and stage IV (aOR=0.58, 95% CI 0.34 – 0.99) were less likely to be tested than those born to mothers with WHO stage I disease progression. CONCLUSION There was an increasing trend in the uptake of HIV testing of infants at age 8 weeks during the study period. However, it is still below the global target. Efforts to promote EID testing are still needed.

We estimated the costs of Option B+ for HIV-infected pregnant women in 12 facilities in Morogoro Region, Tanzania, from a provider perspective. Costs of prevention of mother-to-child (PMTCT) HIV services were measured over 12 months to September 2017 to estimate the average costs per HIV testing episode, per HIV-positive case diagnosed, per patient-year on antiretroviral therapy (ART), and per neonatal HIV care. A one-way sensitivity analysis was undertaken to understand how staffing levels and other core resource inputs affected costs. The total number of HIV testing episodes was 25,593 with 279 HIV cases identified yielding a 1.1% positivity rate. The average cost per testing episode was US$5.49 (range US$2.13 to US$13.93), and the average cost per HIV case detected was US$503.29 (range US$230.61 to US$3330.38). The number of pregnant women initiated on ART was 278. The mean cost per patient-year on ART was US$159.89 (range US$100.91 to US$812.23). The average cost of neonatal HIV care was US$90.09 (range US$41.53 to US$180.26). PMTCT service costs varied widely across facilities due to variations in resource use, number of women testing, and HIV prevalence. The study provides further evidence against generalising cost estimates, and that budgeting and planning requires context specific cost information.

Background : Antiretroviral therapy (ART) for HIV, taken daily, is an effective strategy to clinically suppress the virus, providing the dual benefit of improved survival and vastly decreasing the risk of transmission. However, this highly effective intervention has not yet reached all who could benefit. Cash transfers are increasingly recognized as an effective strategy to motivate behavior change and improve outcomes along the HIV care continuum, including engagement in HIV care and adherence to ART. Despite a growing evidence base and strong theoretical foundation for the cash transfer approach, key questions remain. Specifically, gaps exist in understanding: 1) whether short-term cash transfers can increase viral suppression in larger, effectiveness studies; and 2) an implementation model or set of best practices that facilitate scale up and enhance sustainability. To address these questions and begin to bridge the “know-do gap” with respect to cash transfers, our team is employing an implementation science approach to iterative development of an incentive-based implementation strategy to promote ART uptake and adherence among people living with HIV (PLHIV) in the Lake Zone Region, Tanzania. Methods: We will conduct a type I hybrid implementation – effectiveness trial to test the effectiveness of a cash transfer intervention on the outcome of HIV viral suppression, and concurrently examine the potential for real-world implementation with an mHealth system through measurement of implementation science constructs. Specifically, our team will expand the intervention to 32 clinics and enroll 1,984 PLHIV to (a) evaluate its effectiveness by conducting a cluster randomized controlled trial with clinics as the unit of randomization and 12-month viral suppression as the primary outcome – a key indicator for monitoring progress towards HIV epidemic control; and (b) evaluate the implementation challenges and successes by measuring implementation outcomes at multiple levels (patient, provider, clinic). Discussion: This trial will provide evidence about not only the real-world effectiveness of cash transfers for retention in HIV care and viral suppression, but also on the implementation challenges and successes that will facilitate or hinder wider scale-up within Tanzania and beyond.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

IntroductionTanzania is making an enormous effort in scaling-up of antiretroviral therapy (ART). However, people living with HIV (PLHIV) continue to succumb to the challenge of drug resistance. Evidence on drug resistance for a national survey is unavailable in Tanzania. Therefore, we sought to assess viral suppression (vs) rates and magnitude of acquired drug resistance (ADR) among PLHIV.Methods and analysisA national survey will be conducted from 26 July to 29 October 2021 in 22 regions, recruiting 2160 participants. These will include adults on ART for 9–15 months and ≥48 months and children on ART for 9–15 months and ≥36 months. A standardised questionnaire will capture participants’ demographic and clinical data. Plasma and dried blood spot will be prepared for viral load testing and drug resistance genotyping. Statistical analyses to determine the burden of ADR, characteristics and factors associated therewith will be done using STATA V.15.Ethics and disseminationEthical approval has been obtained from the National Health Research Ethics Committee of Tanzania (NIMR/HQ/R.8a/Vol.IX/3432). Appropriate participant informed consent or parental consent and assent will be obtained. Dissemination will include a survey report, conference presentations, policy briefs and peer-reviewed publications.

Background: In 2014, Tanzania adopted the Option B+ policy for the prevention of mother-to-child transmission of HIV (PMTCT), which stipulates lifelong antiretroviral therapy (ART) for HIV-infected pregnant, postpartum and breastfeeding women, irrespective of CD4 count or WHO clinical staging. Loss to follow-up (LTFU) during pregnancy and the postpartum period may undermine the effectiveness of Option B+. Factors associated with no follow-up (NFU) care, may differ from those associated with LTFU at later time points. This study aimed to identify factors associated with NFU and LTFU among women who initiate ART under Option B+ in Moshi, Tanzania. Methods: We conducted a retrospective chart review of patients initiating ART on Option B+ between February 2014 and December 2015 in Moshi Municipality, Tanzania. Multivariable log-binomial regression was used to analyse factors associated with NFU. Kaplan-Meier survival functions were used to estimate time to LTFU. Multivariable Cox proportion hazards regression models were used to evaluate variables associated with time to LTFU. Results: Among 468 women initiating ART under the option B+ programme, 109 (23.3%) had NFU after the initial appointment. Factors associated with increased risk of NFU were: age < 25 years (adjusted hazard ratio [aRR] 1.7; 95% CI, 1.2 to 2.3), initiating ART at a hospital compared to a lower level health facilities (aRR 2.9; 95% CI, 2.1 to 3.9), and having no treatment supporter (aRR 1.5; 95% CI, 1.1 to 2.1). LTFU was higher in women aged < 25 years (aHR 1.4; 95% CI, 1.1 to 1.9), and in women with no treatment supporter (aHR 1.8; 95% CI, 1.4 to 2.3). In women who returned to the clinic after ART initiation, no factor was significantly associated with LTFU. Conclusion: The factors associated with NFU (being young, not having a treatment supporter, and being diagnosed at hospitals) reflect a vulnerable and potentially highly mobile population. Additional interventions are needed to support and retain this group at ART initiation on Option B+.

Routinely collected clinic data have the potential to provide much needed information on the uptake of services to prevent mother-to-child transmission (PMTCT) of HIV, and to measure HIV prevalence in pregnant women. This article describes the methodological challenges associated with using such data, based on the experiences of researchers and programme implementers in Tanzania and drawing from other examples from East Africa. PMTCT data are routinely collected in maternal and child health (MCH) clinics in East Africa using paper-based registers corresponding to distinct services within the PMTCT service continuum. This format has inherent limitations with respect to maintaining and accurately recording unique identifiers that can link patients across the different clinics (antenatal, delivery, child), and also poses challenges when compiling aggregate data. Recent improvements to recording systems include assigning unique identifiers to HIV-positive pregnant women in MCH clinics, although this should ideally be extended to all pregnant women, and recording mother and infant identifiers alongside each other in registers. The use of 'health passports', as in Malawi, which maintains the same antenatal clinic identifier over time, also holds promise. Routine data hold tremendous potential for clinic-level patient management, surveillance, and evaluating PMTCT/MCH programmes. Linking clinic data to community research datasets can also provide population-level estimates of coverage with PMTCT services, currently a problematic but vital statistic for monitoring programme performance and negotiating donor funding. Enhancements to indexing and recording of routine PMTCT/MCH data are needed if we are to capitalise on this rich data source.

BACKGROUND: Food insecurity is an important barrier to retention in care and adherence to antiretroviral therapy (ART) among people living with HIV infection (PLHIV). However, there is a lack of rigorous evidence about how to improve food security and HIV-related clinical outcomes. To address this gap, this randomized trial will evaluate three delivery models for short-term food and nutrition support for food insecure PLHIV in Shinyanga, Tanzania: nutrition assessment and counseling (NAC) alone, NAC plus food assistance, and NAC plus cash transfers. METHODS/DESIGN: At three HIV care and treatment sites, 788 participants will be randomized into one of three study arms in a 3:3:1 ratio, stratified by site: NAC plus food assistance, NAC plus cash transfer, and NAC only. Eligible participants are: 1) at least 18 years of age; 2) living with HIV infection; 3) initiated ART in the past 90 days; and 4) food insecure, as measured with the Household Hunger Scale. PLHIV who are severely malnourished (body mass index (BMI) < 16 kg/m(2)) will be excluded. Participants randomized to receive food or cash transfers are eligible to receive assistance for up to six months, conditional on attending regularly scheduled visits with their HIV care provider. Participants will be followed for 12 months: the initial 6-month intervention period and then for another 6 months post-intervention. The primary outcome is ART adherence measured with the medication possession ratio. Secondary outcomes include 1) retention in care; 2) nutritional indicators including changes in food security, BMI, and weight gain; 3) viral suppression and self-reported ART adherence; and 4) participation in the labor force. DISCUSSION: This rigorously designed trial will inform policy decisions regarding supportive strategies for food insecure PLHIV in the early stages of treatment. The study will measure outcomes immediately after the period of support ends as well as 6 months later, providing information on the duration of the interventions' effect. The comparison of food to cash transfers will better inform policies favoring cash assistance or will provide rationale for the continued investment in food and nutrition interventions for PLHIV. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01957917.