Rifapentine and isoniazid for prevention of tuberculosis in people with diabetes (PROTID): protocol for a randomised controlled trial.

BACKGROUND: Diabetes mellitus (DM) increases the risk of tuberculosis (TB) and will hamper global TB control due to the dramatic rise in type 2 DM in TB-endemic settings. In this trial, we will examine the efficacy and safety of TB preventive therapy against the development of TB disease in people with DM who have latent TB infection (LTBI), with a 12-week course of rifapentine and isoniazid (3HP). METHODS: The 'Prevention of tuberculosis in diabetes mellitus' (PROTID) consortium will randomise 3000 HIV-negative eligible adults with DM and LTBI, as evidenced by a positive tuberculin skin test or interferon gamma release assay, to 12 weeks of 3HP or placebo. Participants will be recruited through screening adult patients attending DM clinics at referral hospitals in Tanzania and Uganda. Patients with previous TB disease or treatment with a rifamycin medication or isoniazid (INH) in the previous 2 years will be excluded. The primary outcome is the occurrence of definite or probable TB disease; secondary outcome measures include adverse events, all-cause mortality and treatment completion. The primary efficacy analysis will be intention-to-treat; per-protocol analyses will also be carried out. We will estimate the ratio of TB incidence rates in intervention and control groups, adjusting for the study site using Poisson regression. Results will be reported as efficacy estimates (1-rate ratio). Cumulative incidence rates allowing for death as a competing risk will also be reported. Approximately 1000 LTBI-negative, HIV-negative participants will be enrolled consecutively into a parallel cohort study to compare the incidence of TB in people with DM who are LTBI negative vs positive. A number of sub-studies will be conducted among others to examine the prevalence of LTBI and active TB, estimate the population impact and cost-effectiveness of LTBI treatment in people living with DM in these African countries and address gaps in the prevention and therapeutic management of combined TB-DM. DISCUSSION: PROTID is anticipated to generate key evidence to guide decisions over the use of TB preventive treatment among people with DM as an important target group for better global TB control. TRIAL REGISTRATION: ClinicalTrials.gov NCT04600167 . Registered on 23 October 2020

Indicators of optimal diabetes care and burden of diabetes complications in Africa: a systematic review and meta-analysis.

OBJECTIVE: Contemporary data on the attainment of optimal diabetes treatment goals and the burden of diabetes complications in adult populations with type 2 diabetes in Africa are lacking. We aimed to document the current status of attainment of three key indicators of optimal diabetes care and the prevalence of five diabetes complications in adult African populations with type 2 diabetes. METHODS: We systematically searched Embase, PubMed and the Cochrane library for published studies from January 2000 to December 2020. Included studies reported any information on the proportion of attainment of optimal glycated haemoglobin (HbA1c), blood pressure (BP) and low-density lipoprotein cholesterol (LDLC) goals and/or prevalence of five diabetes complications (diabetic peripheral neuropathy, retinopathy, nephropathy, foot ulcers and peripheral arterial disease). Random effect model meta-analysis was performed to determine the pooled proportion of attainment of the three treatment goals and the prevalence of five diabetes complications. RESULTS: In total, 109 studies with a total of 63 890 participants (53.3% being females) were included in the meta-analysis. Most of the studies were conducted in Eastern African countries (n=44, 40.4%). The pooled proportion of attainment of an optimal HbA1c, BP and LDLC goal was 27% (95% CI 24 to 30, I2=94.7%), 38% (95% CI 30 to 46, I2=98.7%) and 42% (95% CI 32 to 52, I2=97.4%), respectively. The pooled prevalence of diabetic peripheral neuropathy, retinopathy, diabetic nephropathy, peripheral arterial disease and foot ulcers was 38% (95% CI 31 to 45, I2=98.2%), 32% (95% CI 28 to 36, I2=98%), 31% (95% CI 22 to 41, I2=99.3%), 19% (95% CI 12 to 25, I2=98.1%) and 11% (95% CI 9 to 14, I2=97.4%), respectively. CONCLUSION: Attainment of optimal diabetes treatment goals, especially HbA1c, in adult patients with type 2 diabetes in Africa remains a challenge. Diabetes complications, especially diabetic peripheral neuropathy and retinopathy, are highly prevalent in adult populations with type 2 diabetes in Africa

Burden and associated phenotypic characteristics of tuberculosis infection in adult Africans with diabetes: a systematic review.

Diabetes mellitus (DM) increases the risk of developing tuberculosis infection (TBI). However, the evidence on the burden and phenotypic characteristics of TBI in African patients with DM is limited. This study aimed to determine the prevalence and characterisation of TBI in native African patients living with DM. We searched PubMed, EMBASE, and African Journals Online for original studies reporting information on the prevalence and characteristics of TBI in adult Africans with DM. A forest plot was used to describe the pooled prevalence estimate of TBI and the corresponding 95% confidence intervals (CI). Six studies conducted in four African countries involving 721 participants with DM were included in this systematic review. The pooled prevalence estimate of TBI was 40% (95% CI 20-60%, I2 = 98.52%, p < 0.001). Age ≥ 40 years and glycated haemoglobin levels independently predicted TBI positivity in patients with DM in three studies. Africans with DM have a high prevalence of TBI, especially those who are older or with poorly controlled diabetes. This justifies the need for studies to explore how to screen and manage TBI to avert the progression to active TB disease

Mate Yako Afya Yako: Formative research to develop the Tanzania HIV self-testing education and promotion (Tanzania STEP) project for men.

The purpose of this formative research, guided by the Integrated Behavioral Model, was to assess men's attitudes and personal agency towards HIV self-testing (HIVST) and confirmatory HIV testing in order to inform the development of the Tanzania STEP (Self-Testing Education and Promotion) Project, a peer-based HIV self-testing intervention for young men in Tanzania. Qualitative in-depth interviews were conducted with 23 men in Dar es Salaam, Tanzania who socialize in networks locally referred to as "camps". Men reported privacy, confidentiality, and saving time as the primary reasons for their self-testing interest. Most participants had high perceived control and self-efficacy to self-test and seek confirmatory HIV testing. Nevertheless, men reported concerns related to their ability to perform the test and the potential lack of post-test counseling. Specific recommendations for the intervention included providing HIVST education and pre-test counseling, and using mobile health (mHealth) strategies for participants to reach a healthcare professional for further assistance. The findings suggest that while HIVST is highly acceptable among men in Tanzania, future interventions will need to address the challenges that men may face with HIVST before promoting it as an alternative or supplement to facility-based HIV testing

Results from a cluster-randomized trial to evaluate a microfinance and peer health leadership intervention to prevent HIV and intimate partner violence among social networks of Tanzanian men.

Despite calls to engage men in HIV and intimate partner violence (IPV) prevention efforts, effective approaches to reach and engage men in low-resource, high-HIV prevalence settings are limited. We identified and engaged social networks of mostly young men in a study designed to evaluate the efficacy of a combined microfinance and peer health leadership intervention to prevent HIV and IPV. We conducted a cluster-randomized trial among 60 social networks locally referred to as "camps" within Dar es Salaam, Tanzania. Camps were randomly assigned (1:1) to a microfinance and peer health leadership intervention or a control condition that received a brief delayed intervention after the study's conclusion. Allocation was not masked to participants or researchers. Behavioral assessments were conducted at baseline and 30-months post-intervention launch, with biological samples drawn at 30-months to test for sexually-transmitted infections (STIs). Primary outcomes included prevalence of STIs and past-year IPV perpetration. Secondary outcomes included STI sexual risk behaviors and past-year HIV testing. Proximal intervention targets included inequitable gender norm attitudes and hope. A modified Poisson regression approach was used to estimate intention-to-treat intervention effects on outcomes assessed at the 30-month follow-up. We enrolled 1,258 men within 60 camps. Of these men, 1,029 (81.8%) completed the 30-month follow-up. There were no differences by condition in STI prevalence, IPV perpetration, or sexual risk behaviors at the 30-month follow-up. Intervention participants reported greater levels of past-year HIV testing, controlling for baseline testing (aRR 1.13 95% CI 1.005-1.28). They also reported significantly lower levels of inequitable gender norm attitudes (adjusted effect -0.11, 95% CI -0.21-0.003). We successfully engaged and retained social networks of men in this multilevel intervention study. While we did not see an effect on the primary outcomes, our intervention successfully improved HIV testing and reduced inequitable gender norm attitudes

Microfinance and health interventions: Factors influencing loan repayment success with young men in Dar es Salaam, Tanzania

Poverty is associated with numerous poor health outcomes. Youth unemployment in Tanzania is approximately 13.7%, and concentrates in urban areas. These youth lack relevant job skills and access to financial capital. Microfinance continues to be implemented globally to address poverty, and increasingly has been linked to health interventions. Men less frequently are recipients of microfinance loans. We offered microcredit to young men in an area of Dar es Salaam with high poverty as part of a randomised controlled-trial to assess the efficacy of a microfinance and health leadership intervention in preventing STI acquisition. We used mixed methods to understand predictors of successful loan repayment. Our qualitative sub-study showed that leader influence, prior business experience, personal motivation, and planning facilitated repayment. Using a modified Poisson approach, our quantitative analysis showed that successful repayment was associated with business experience, education, increasing number of children, community of residence, percentage of network members trained in business, and repayment success of peer leaders. Our results suggest that enforcing group accountability and repayment rules, offering ongoing training, and using successful entrepreneurs as role models could increase repayment success in similar populations. These strategies could provide financial opportunity for men while minimising risk for microfinance institutions