Barriers to viral load suppression among adolescents living with HIV on anti-retroviral therapy: a retrospective study in Tanga, Tanzania.

BACKGROUND: Despite the decreased incidence of the human immunodeficiency virus (HIV) in Tanzania, the number of adolescents living with HIV is increasing. This study aimed to describe factors independently associated with viral load non-suppression among adolescents living with HIV (ALHIV) on ART in the Tanga region. METHODS: We conducted a retrospective study of routinely collected data from ALHIV on ART from October 2018 to April 2022. We extracted data from the Care and Treatment Clinics form number 2 (CTC2) database that included age, sex, BMI, World Health Organization HIV clinical disease stage, marital status, ART duration, viral load suppression, facility level, and Dolutegravir (DTG)-based regimen. We did descriptive analysis using frequencies to describe the study participants' socio-demographic and clinical characteristics. The Cox proportional hazard regression model was used to identify factors associated with viral load non-suppression (VLS). Viral load non-suppression was defined as viral load ≥ 1000 copies/ml. A total of 4735 ALHIV on ART were extracted from CTC2, then 2485 were excluded (2186 missed viral load results, 246 were lost to follow-up, and 53 deaths). RESULTS: 2250 ALHIV on ART were tested for viral load, of whom 2216 (98.62%) adolescents were on first-line ART, and 2024 (89.96%) participants were virally suppressed, while 226 (10.04%) were virally non-suppressed. In addition, 2131 (94.71%) of participants were using a DTG-based regimen; of them, 1969 (92.40%) were virally suppressed. Not using a DTG-based regimen (HR: 9.36, 95% CI 3.41-15.31) and dispensary facility level (HR: 3.61, 95% CI 1.44-7.03) were independently associated with increased hazard for viral load non-suppression. In addition, adolescents aged between 15 and 19 years are less likely to be virally suppressed (HR: 0.55, 95% CI 0.30-0.99). CONCLUSIONS: The dispensary facility level and not using a DTG-based regimen were significantly associated with viral load non-suppression. HIV intervention strategies should ensure a DTG-based regimen utilization in all adolescents living with HIV, and techniques used by higher-level health facilities should be disseminated to lower-level facilities.

Determinants of viral load suppression failure among HIV adults on ARV attending health care facilities: a retrospective study in Tanga region, Tanzania.

BACKGROUND: Availability and accessibility of Antiretroviral drugs (ARV's) improve the lives of People living with HIV (PLHIV) by improving client's immune system to overcome infections and prevent the development of AIDS and other HIV complications. Combination therapy, early initiation of ART, newer ART drugs, single dosage and drug affordability significantly contribute in the reduction of viral multiplication and suppression of HIV to undetectable plasma levels. METHODS: A retrospective longitudinal study design study was conducted from 1st October, 2018 to 30th June 2022 in all supported HIV care and treatment health facilities in Tanga region which were supported by Amref Health Africa, Tanzania. The participants were HIV adult patients aged 15 years and above on ART and attended the clinic at least once after ART initiation. Viral load suppression levels are defined with viral load <1,000 HIV RNA copies/ml (viral load suppression). Cox proportional hazard regression models were employed to identify risk factors for virological failure. P values were two-sided, and we considered a P<0.05 to be statistically significant. RESULTS: Fifty-nine thousand five hundred three adult clients >15 years whom were on ART were included in the analysis to determine the level of plasma Viral Load suppression after being on ART. Female 41,304 (69.4%) and male 18,199 (30.6%). Only four percent (2,290) were found to be unsuppressed i.e having plasma Viral Load >1,000cp/ml while 96% (57,213) were virally suppressed. Several factors were independently associated with virologic failure that included; age between 15 - <25 years (HR: 2.82, 95% CI 1.96 - 4.04), BMI <18.5 (HR: 1.69, 95% CI 1.23 - 2.30), advanced WHO stage IV (HR: 1.60, 95% CI 1.12 - 2.24), CD4 cell count <350 (HR: 2.61, 95% CI 2.12 - 3.23), poor adherence (HR: 1.98, 95% CI 1.80 - 2.18) and not using DTG based drug (HR: 11.8, 95% CI 9.74 - 14.3). CONCLUSION: Virologic failure was observed in this study among clients with young age, advanced WHO stage IV, not using DTG based regimen, poor drug adherence and second line regime. To improve Viral Load Suppression among these clients; the existing HIV intervention strategies should be taken care by targeting the identified risk factors.

Risk factors for interruption in treatment among HIV-infected adolescence attending health care and treatment clinics in Tanzania.

BACKGROUND: Interruption in Treatment (IIT) is a challenge in HIV care and treatment programs in sub- Saharan Africa. High IIT among HIV adolescents has both individual and potential public health consequences including discontinuation of treatment, increased HIV transmission and risk of death. In this era of test and treat policy it is important to ensure that patients remain connected to HIV clinics to enable achieve UNAIDS 95-95-95 targets timely. This study aimed to assess risk factors for IIT among HIV-positive adolescence in Tanzania. METHODS: We conducted retrospective longitudinal cohort study using secondary data of adolescent patients enrolled in care and treatment clinics in Tanga from October 2018 to December 2020. We defined Interuption in Treatment as missing clinic visits for 90 consecutive days after the last scheduled appointment date on anti-retroviral therapy (ART). Cox proportional hazard regression models were employed to identify risk factors of the outcome variable. RESULTS: Among 2,084 adolescents of age between 15 and 19 years were followed for two years, whereby 546 (26.2%) had interrupted treatment. The median age of the participants was 14.6 years (interquartile range, IQR: 12.6-16.6 years), with age between 15 and 19 years, male sex, with advanced HIV disease and were not on Dolutegravir (DTG) related regimens were associated with interruption in treatment; (Hazard ratio (HR) 1.43, 95% CI: 1.23-1.66, p < 0.0001, HR 2.47, 95% CI: 1.62-3.77, p < 0.0001, HR: 2.47, 95% CI: 1.91- 3.21, p < 0.0001 and HR: 6.67, 95% CI: 3.36- 7.04, p < 0.0001 respectively). Adolescents who were on ART for less or equal one year compared to those on ART for more than one year were protective toward interruption in treatment (HR: 0.68, 95% CI: 0.54-0.87, p = 0.002). CONCLUSIONS: The risk of interruption in treatment was high among adolescents in HIV care and treatment facilities in Tanga. This might lead to poor clinical outcomes, and increased drug resistance among ART-initiated adolescents. Placing more adolescents with DTG based drug, strengthening access to care and treatment and rapid tracking of patients is recommended to improve patient outcomes.

Predictors of the observed high prevalence of loss to follow-up in ART-experienced adult PLHIV: a retrospective longitudinal cohort study in the Tanga Region, Tanzania.

BACKGROUND: Antiretroviral therapy (ART) programs have expanded rapidly, and they are now accessible free of charge, yet "loss to follow-up, LTFU" is still a national public health issue. LTFU may result in treatment failure, hospitalization, increased risk of opportunistic infections and drug-resistant strains, and shortening the quality of life. This study described the rates and predictors of LTFU among adults living with human immunodeficiency virus (PLHIV) on ART in the Tanga region, Tanzania. METHODS: A retrospective longitudinal cohort study was conducted between October 2018 and December 2020 in Tanga's care and treatment health services facilities. The participants were HIV adult PLHIV aged 15 years and above on ART and attended the clinic at least once after ART initiation. LTFU was defined as not taking ART refills for 3 months or beyond from the last attendance of a refill and not yet classified as dead or transferred out. Cox proportional hazard regression models were employed to identify risk factors for LTFU. P values were two-sided, and we considered a p < 0.05 statistically significant. RESULTS: 57,173 adult PLHIV were on ART of them, 15,111 (26.43%) were LTFU, of whom 10,394 (68.78%) were females, and 4717 (31.22%) were males. Factors independently associated with LTFU involved age between 15 and 19 years (HR: 1.85, 95% CI 1.66-2.07), male sex (HR: 2.00 95% CI 1.51-2.62), divorce (HR: 1.35, 95% CI 1.24-1.48), second-line drug type (HR: 1.13, 95% CI 1.09-1.18), poor drug adherence (HR: 1.50, 95% CI 1.23-1.75), unsuppressed viral load (HR: 2.15, 95% CI 2.02-2.29), not on DTG-related drug (HR: 7.51, 95% CI 5.88-10.79), advanced HIV disease WHO stage III and IV (HR: 2.51, 95% CI 2.32-2.72). In contrast to cohabiting, ART duration < 1 year, and being pregnant showed a reduced likelihood of LTFU. CONCLUSION: A high prevalence of LTFU was observed in this study. Young age, not using DTG-based regimen, WHO clinical stage IV, poor drug adherence, male sex, unsuppressed viral load, divorcee, and second-line regime were independently associated with LTFU. To reduce LTFU, evidence-based interventions targeting the identified risk factors should be employed.

The impact of a community health worker intervention on uptake of antenatal care: a cluster-randomized pragmatic trial in Dar es Salaam.

The provision of high-quality antenatal care (ANC) is important for preventing maternal and newborn mortality and morbidity, but only around half of pregnant women in Tanzania attended four or more ANC visits in 2019. Although there is emerging evidence on the benefit of community health worker (CHW) interventions on ANC uptake, few large-scale pragmatic trials have been conducted. This pragmatic cluster-randomized trial, implemented directly through the public sector health system, assessed the impact of an intervention that trained public sector CHWs to promote the uptake of ANC. We randomized 60 administrative wards in Dar es Salaam to either a targeted CHW intervention or a standard of care. The impact of the intervention was assessed using generalized estimating equations with an independent working correlation matrix to account for clustering within wards. A total of 243 908 women were included in the analysis of our primary outcome of four or more ANC visits. The intervention significantly increased the likelihood of attending four or more ANC visits [relative risk (RR): 1.42; 95% confidence interval (CI): 1.05, 1.92] and had a modest beneficial effect on the total number of ANC visits (percent change: 7.7%; 95% CI: 0.2%, 15.5%). While slightly more women in the intervention arm attended ANC in their first trimester compared with the standard-of-care arm (19% vs 18.7%), the difference was not significant (RR: 1.02; 95% CI: 0.84, 1.22). Our findings suggest that trained CHWs can increase attendance of ANC visits in Dar es Salaam and similar settings. However, additional interventions appear necessary to promote the early initiation of ANC. This study demonstrates that routine health system data can be leveraged for outcome assessment in trials and programme evaluation and that the results are likely superior, both in terms of bias and precision, to data that are collected specifically for science.

Willingness to pay for community delivery of antiretroviral treatment in urban Tanzania: a cross-sectional survey.

Community health worker (CHW)-led community delivery of HIV antiretroviral therapy (ART) could increase ART coverage and decongest healthcare facilities. It is unknown how much patients would be willing to pay to receive ART at home and, thus, whether ART community delivery could be self-financing. Set in Dar es Salaam, this study aimed to determine patients' willingness to pay (WTP) for CHW-led ART community delivery. We sampled ART patients living in the neighbourhoods surrounding each of 48 public-sector healthcare facilities in Dar es Salaam. We asked participants (N = 1799) whether they (1) preferred ART community delivery over standard facility-based care, (2) would be willing to pay for ART community delivery and (3) would be willing to pay each of an incrementally increasing range of prices for the service. 45.0% (810/1799; 95% CI: 42.7-47.3) of participants preferred ART community delivery over standard facility-based care and 51.5% (417/810; 95% CI: 48.1-55.0) of these respondents were willing to pay for ART community delivery. Among those willing to pay, the mean and median amount that participants were willing to pay for one ART community delivery that provides a 2-months' supply of antiretroviral drugs was 3.61 purchasing-power-parity-adjusted dollars (PPP$) (95% CI: 2.96-4.26) and 1.27 PPP$ (IQR: 1.27-2.12), respectively. An important limitation of this study is that participants all resided in neighbourhoods within the catchment area of the healthcare facility at which they were interviewed and, thus, may incur less costs to attend standard facility-based ART care than other ART patients in Dar es Salaam. While there appears to be a substantial WTP, patient payments would only constitute a minority of the costs of implementing ART community delivery. Thus, major co-financing from governments or donors would likely be required.

Structural, interpersonal, psychosocial, and behavioral risk factors for HIV acquisition among female bar workers in Dar es Salaam, Tanzania.

In sub-Saharan Africa, female bar workers (FBWs) often serve as informal sex workers. Little is known about the prevalence of HIV and HIV-related risk factors among FBWs in Dar es Salaam (DSM), Tanzania. Using an adapted Structural HIV Determinants Framework, we identified structural, interpersonal, psychosocial, and behavioral risk factors for HIV acquisition. We compared the prevalence of HIV and HIV-related risk factors among a random sample of 66 FBWs from DSM to an age-standardized, representative sample of female DSM-residents from the 2016 Demographic and Health and 2011-2012 AIDS Indicator Surveys. Compared to other women in DSM, FBWs had elevated prevalence of all four groups of risk factors. Key risk factors included gender and economic inequalities (structural); sexual violence and challenges negotiating condom use (interpersonal); depression, post-traumatic stress disorder, and low social support (psychosocial); and history of unprotected sex, multiple sex partners, and high alcohol consumption (behavioral). HIV prevalence did not differ between FBWs (7.1%, 95% CI 3.7-13.3%) and survey respondents (7.7%, 95% CI: 5.3-11.1%), perhaps due to FBWs' higher - though sub-optimal - engagement with HIV prevention strategies. Elevated exposure to HIV-related risk factors but low HIV prevalence suggests economic, psychosocial, and biomedical interventions may prevent HIV among FBWs in DSM.

HIV risk and pre-exposure prophylaxis interest among female bar workers in Dar es Salaam: cross-sectional survey.

OBJECTIVE: Female bar workers (FBW) in East Africa often conduct sex work to supplement their incomes, and may be vulnerable to HIV acquisition. Pre-exposure prophylaxis (PrEP) offers protection against HIV acquisition. However, there is little research on FBW's sexual health. Our objective was to determine HIV risk behaviours and interest in PrEP among FBW in the largest city in East Africa. DESIGN: Cross-sectional survey covering respondents' work and personal lives, including social and behavioural risk factors for HIV. The survey aimed to determine the feasibility of working with FBW and HIV prevalence estimates. Those who did not report being HIV positive were asked about their knowledge of and interest in PrEP. All women were offered free on-site HIV testing and counselling (HTC). SETTING: Eight randomly selected workplaces, that is, bars, in Kinondoni district, Dar es Salaam (DSM). PARTICIPANTS: 66 FBW (≥18 years) selected at random from all women working in selected bars on the day of visit. RESULTS: Half of respondents reported having had sex for money: 20% with bar clients only, 15% with other men only and 15% with both. Almost all (98%) reported ≥1 non-commercial partners in the past 12 months; only 30% reported using condoms with these partners. 85% of respondents had ever been pregnant; 44% had had an unintended pregnancy. Only 5% of respondents had ever heard of PrEP. However, 54% were somewhat/very interested in daily-pill PrEP and 79% were somewhat/very interested in long-acting injectable PrEP. When asked to rank modalities, long-acting injectable PrEP was the most preferred. Seven per cent of the 56 respondents who completed HTC tested HIV positive. CONCLUSIONS: FBW in DSM have elevated risk factors for HIV acquisition, and PrEP appears highly acceptable. Studies developing PrEP delivery models and assessing PrEP initiation and adherence in FBW appear warranted.

Community health workers to improve uptake of maternal healthcare services: A cluster-randomized pragmatic trial in Dar es Salaam, Tanzania.

BACKGROUND: Home delivery and late and infrequent attendance at antenatal care (ANC) are responsible for substantial avoidable maternal and pediatric morbidity and mortality in sub-Saharan Africa. This cluster-randomized trial aimed to determine the impact of a community health worker (CHW) intervention on the proportion of women who (i) visit ANC fewer than 4 times during their pregnancy and (ii) deliver at home. METHODS AND FINDINGS: As part of a 2-by-2 factorial design, we conducted a cluster-randomized trial of a home-based CHW intervention in 2 of 3 districts of Dar es Salaam from 18 June 2012 to 15 January 2014. Thirty-six wards (geographical areas) in the 2 districts were randomized to the CHW intervention, and 24 wards to the standard of care. In the standard-of-care arm, CHWs visited women enrolled in prevention of mother-to-child HIV transmission (PMTCT) care and provided information and counseling. The intervention arm included additional CHW supervision and the following additional CHW tasks, which were targeted at all pregnant women regardless of HIV status: (i) conducting home visits to identify pregnant women and refer them to ANC, (ii) counseling pregnant women on maternal health, and (iii) providing home visits to women who missed an ANC or PMTCT appointment. The primary endpoints of this trial were the proportion of pregnant women (i) not making at least 4 ANC visits and (ii) delivering at home. The outcomes were assessed through a population-based household survey at the end of the trial period. We did not collect data on adverse events. A random sample of 2,329 pregnant women and new mothers living in the study area were interviewed during home visits. At the time of the survey, the mean age of participants was 27.3 years, and 34.5% (804/2,329) were pregnant. The proportion of women who reported having attended fewer than 4 ANC visits did not differ significantly between the intervention and standard-of-care arms (59.1% versus 60.7%, respectively; risk ratio [RR]: 0.97; 95% CI: 0.82-1.15; p = 0.754). Similarly, the proportion reporting that they had attended ANC in the first trimester did not differ significantly between study arms. However, women in intervention wards were significantly less likely to report having delivered at home (3.9% versus 7.3%; RR: 0.54; 95% CI: 0.30-0.95; p = 0.034). Mixed-methods analyses of additional data collected as part of this trial suggest that an important reason for the lack of effect on ANC outcomes was the perceived high economic burden and inconvenience of attending ANC. The main limitations of this trial were that (i) the outcomes were ascertained through self-report, (ii) the study was stopped 4 months early due to a change in the standard of care in the other trial that was part of the 2-by-2 factorial design, and (iii) the sample size of the household survey was not prespecified. CONCLUSIONS: A home-based CHW intervention in urban Tanzania significantly reduced the proportion of women who reported having delivered at home, in an area that already has very high uptake of facility-based delivery. The intervention did not affect self-reported ANC attendance. Policy makers should consider piloting, evaluating, and scaling interventions to lessen the economic burden and inconvenience of ANC. TRIAL REGISTRATION: ClinicalTrials.gov NCT01932138.

The effect of a community health worker intervention on public satisfaction: evidence from an unregistered outcome in a cluster-randomized controlled trial in Dar es Salaam, Tanzania.

BACKGROUND: There is a dearth of evidence on the causal effects of different care delivery approaches on health system satisfaction. A better understanding of public satisfaction with the health system is particularly important within the context of task shifting to community health workers (CHWs). This paper determines the effects of a CHW program focused on maternal health services on public satisfaction with the health system among women who are pregnant or have recently delivered. METHODS: From January 2013 to April 2014, we carried out a cluster-randomized controlled health system implementation trial of a CHW program. Sixty wards in Dar es Salaam, Tanzania, were randomly allocated to either a maternal health CHW program (36 wards) or the standard of care (24 wards). From May to August 2014, we interviewed a random sample of women who were either currently pregnant or had recently delivered a child. We used five-level Likert scales to assess women's satisfaction with the CHW program and with the public-sector health system in Dar es Salaam. RESULTS: In total, 2329 women participated in the survey (response rate 90.2%). Households in intervention areas were 2.3 times as likely as households in control areas to have ever received a CHW visit (95% CI 1.8, 3.0). The intervention led to a 16-percentage-point increase in women reporting they were satisfied or very satisfied with the CHW program (95% CI 3, 30) and a 15-percentage-point increase in satisfaction with the public-sector health system (95% CI 3, 27). CONCLUSIONS: A CHW program for maternal and child health in Tanzania achieved better public satisfaction than the standard CHW program. Policy-makers and implementers who are involved in designing and organizing CHW programs should consider the potential positive impact of the program on public satisfaction. TRIAL REGISTRATION: ClinicalTrials.gov, EJF22802.

Community delivery of antiretroviral drugs: A non-inferiority cluster-randomized pragmatic trial in Dar es Salaam, Tanzania.

BACKGROUND: With the increase in people living with HIV in sub-Saharan Africa and expanding eligibility criteria for antiretroviral therapy (ART), there is intense interest in the use of novel delivery models that allow understaffed health systems to successfully deal with an increasing demand for antiretroviral drugs (ARVs). This pragmatic randomized controlled trial in Dar es Salaam, Tanzania, evaluated a novel model of ARV community delivery: lay health workers (home-based carers [HBCs]) deliver ARVs to the homes of patients who are clinically stable on ART, while nurses and physicians deliver standard facility-based care for patients who are clinically unstable. Specifically, the trial aimed to assess whether the ARV community delivery model performed at least equally well in averting virological failure as the standard of care (facility-based care for all ART patients). METHODS AND FINDINGS: The study took place from March 1, 2016, to October 27, 2017. All (48) healthcare facilities in Dar es Salaam that provided ART and had an affiliated team of public-sector HBCs were randomized 1:1 to either (i) ARV community delivery (intervention) or (ii) the standard of care (control). Our prespecified primary endpoint was the proportion of adult non-pregnant ART patients with virological failure at the end of the study period. The prespecified margin of non-inferiority was a risk ratio (RR) of 1.45. The mean follow-up period was 326 days. We obtained intent-to-treat (ITT) RRs using a log-binomial model adjusting standard errors for clustering at the level of the healthcare facility. A total of 2,172 patients were enrolled at intervention (1,163 patients) and control (1,009 patients) facilities. Of the 1,163 patients in the intervention arm, 516 (44.4%) were both clinically stable on ART and opted to receive ARVs in their homes or at another meeting point of their choosing in the community. At the end of the study period, 10.9% (95/872) of patients in the control arm and 9.7% (91/943) in the intervention arm were failing virologically. The ITT RR for virological failure demonstrated non-inferiority of the ARV community delivery model (RR 0.89 [1-sided 95% CI 0.00-1.18]). We observed no significant difference between study arms in self-reported patient healthcare expenditures over the last 6 months before study exit. Of those who received ARVs in the community, 97.2% (95% CI 94.7%-98.7%) reported being either "satisfied" or "very satisfied" with the program. Other than loss to follow-up (18.9% in the intervention and 13.6% in the control arm), the main limitation of this trial was that substantial decongestion of healthcare facilities was not achieved, thus making the logic for our preregistered ITT approach (which includes those ineligible to receive ARVs at home in the intervention sample) less compelling. CONCLUSIONS: In this study, an ARV community delivery model performed at least as well as the standard of care regarding the critical health indicator of virological failure. The intervention did not significantly reduce patient healthcare expenditures, but satisfaction with the program was high and it is likely to save patients time. Policy-makers should consider piloting, evaluating, and scaling more ambitious ARV community delivery programs that can reach higher proportions of ART patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02711293.

The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania.

BACKGROUND: Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) may improve ART retention by reducing the time burden and out-of-pocket expenditures to regularly attend an ART clinic. In addition, ART home delivery may shorten waiting times and improve quality of care for those in facility-based care by decongesting ART clinics. This trial aims to determine whether ART home delivery for patients who are clinically stable on ART combined with facility-based care for those who are not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression. METHODS: This is a non-inferiority cluster-randomized trial set in Dar es Salaam, Tanzania. A cluster is one of 48 healthcare facilities with its surrounding catchment area. 24 clusters were randomized to ART home delivery and 24 to the standard of care. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART and CHW home visits without ART home delivery). In addition, half of the healthcare facilities in each study arm were randomized to standard counseling during home visits (covering family planning, prevention of HIV transmission, and ART adherence), and half to standard plus nutrition counseling (covering food production and dietary advice). The non-inferiority design applies to the endpoints of the ART home delivery trial; the primary endpoint is the proportion of ART patients at a healthcare facility who are virally suppressed at the end of the study period. The margin of non-inferiority for this primary endpoint was set at nine percentage points. DISCUSSION: As the number of ART patients in sub-Saharan Africa is expected to rise, this trial provides causal evidence on the effectiveness of a home-based care model that could decongest ART clinics and reduce patients' healthcare expenditures. More broadly, this trial will inform the increasing policy interest in task-shifting of chronic disease care from facility- to community-based healthcare workers. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02711293 . Registration date: 16 March 2016.