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.

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.

Controlled human malaria infection of Tanzanians by intradermal injection of aseptic, purified, cryopreserved Plasmodium falciparum sporozoites.

Controlled human malaria infection (CHMI) by mosquito bite has been used to assess anti-malaria interventions in > 1,500 volunteers since development of methods for infecting mosquitoes by feeding on Plasmodium falciparum (Pf) gametocyte cultures. Such CHMIs have never been used in Africa. Aseptic, purified, cryopreserved Pf sporozoites, PfSPZ Challenge, were used to infect Dutch volunteers by intradermal injection. We conducted a double-blind, placebo-controlled trial to assess safety and infectivity of PfSPZ Challenge in adult male Tanzanians. Volunteers were injected intradermally with 10,000 (N = 12) or 25,000 (N = 12) PfSPZ or normal saline (N = 6). PfSPZ Challenge was well tolerated and safe. Eleven of 12 and 10 of 11 subjects, who received 10,000 and 25,000 PfSPZ respectively, developed parasitemia. In 10,000 versus 25,000 PfSPZ groups geometric mean days from injection to Pf positivity by thick blood film was 15.4 versus 13.5 (P = 0.023). Alpha-thalassemia heterozygosity had no apparent effect on infectivity. PfSPZ Challenge was safe, well tolerated, and infectious.

Comparison of bioavailability between the most available generic tablet formulation containing artemether and lumefantrine on the Tanzanian market and the innovator's product.

BACKGROUND: Existence of anti-malarial generic drugs with low bioavailability marketed on sub-Saharan Africa raises a concern on patients achieving therapeutic concentrations after intake of such products. This work compared bioavailability of one generic tablet formulation with innovator's product. Both were fixed dose combination tablet formulations containing artemether and lumefantrine. METHODOLOGY: The study was conducted in Dar Es Salaam, Tanzania, in which a survey of the most abundant generic containing artemether-lumefantrine tablet formulation was carried out in retail pharmacies. The most widely available generic (Artefan®, Ajanta Pharma Ltd, Maharashtra, India) was sampled for bioavailability comparison with Coartem® (Novartis Pharma, Basel, Switzerland)--the innovator's product. A randomized, two-treatment cross-over study was conducted in 18 healthy Tanzanian black male volunteers. Each volunteer received Artefan® (test) and Coartem® (as reference) formulation separated by 42 days of drug-free washout period. Serial blood samples were collected up to 168 hours after oral administration of a single dose of each treatment. Quantitation of lumefantrine plasma levels was done using HPLC with UV detection. Bioequivalence of the two products was assessed in accordance with the US Food and Drug Authority (FDA) guidelines. RESULTS: The most widely available generic in pharmacies was Artefan® from India. All eighteen enrolled volunteers completed the study and both test and reference tablet formulations were well tolerated. It was possible to quantify lumefantrine alone, therefore, the pharmacokinetic parameters reported herein are for lumefantrine. The geometric mean ratios for Cmax, AUC0-t and AUC0-∞ were 84% in all cases and within FDA recommended bioequivalence limits of 80%-125%, but the 90% confidence intervals were outside FDA recommended limits (CI 49-143%, 53-137%, 52-135% respectively). There were no statistical significant differences between the two formulations with regard to PK parameters (P > 0.05). CONCLUSIONS: Although the ratios of AUCs and Cmax were within the acceptable FDA range, bioequivalence between Artefan® and Coartem® tablet formulations was not demonstrated due to failure to comply with the FDA 90% confidence interval criteria. Based on the observed total drug exposure (AUCs), Artefan® is likely to produce a similar therapeutic response as Coartem®.