Experiences on Recruitment and Retention of Volunteers in the First HIV Vaccine Trial in Dar es Salam, Tanzania - The phase I/II HIVIS 03 trial.

Eventual control of HIV/AIDS is believed to be ultimately dependent on a safe, effective and affordable vaccine. Participation of sub-Saharan Africa in the conduct of HIV trials is crucial as this region still experiences high HIV incidences. We describe the experience of recruiting and retaining volunteers in the first HIV vaccine trial (HIVIS03) in Tanzania. In this trial enrolled volunteers from amongst Police Officers (POs) in Dar es Salaam were primed with HIV-1 DNA vaccine at months 0, 1 and 3; and boosted with HIV-1 MVA vaccine at months 9 and 21. A stepwise education provision/sensitization approach was employed to eventual recruitment. Having identified a "core" group of POs keen on HIV prevention activities, those interested to participate in the vaccine trial were invited for a first screening session that comprised of provision of detailed study information and medical evaluation. In the second screening session results of the initial assessment were provided and those eligible were assessed for willingness to participate (WTP). Those willing were consented and eventually randomized into the trial having met the eligibility criteria. Voluntary participation was emphasized throughout. Out of 408 POs who formed the core group, 364 (89.0%) attended the educational sessions. 263 out of 364 (72.2%) indicated willingness to participate in the HIV vaccine trial. 98% of those indicating WTP attended the pre-screening workshops. 220 (85.0%) indicated willingness to undergo first screening and 177 POs attended for initial screenings, of whom 162 (91.5%) underwent both clinical and laboratory screenings. 119 volunteers (73.5%) were eligible for the study. 79 were randomized into the trial, while 19 did not turn up, the major reason being partner/family advice. 60 volunteers including 15 females were recruited during a one-year period. All participated in the planned progress updates workshops. Retention into the schedule was: 98% for the 3 DNA/placebo vaccinations, while it was 83% and 73% for the first and second MVA/placebo vaccinations respectively. In this first HIV vaccine trial in Tanzania, we successfully recruited the volunteers and there was no significant loss to follow up. Close contact and updates on study progress facilitated the observed retention rates.\u

HIV-1 infection in Tanzania with special reference to early diagnosis in children and preparations for vaccine trials

The studies reported in this thesis aimed at identifying simple, suitable and affordable assays for HIV monitoring and for early diagnosis in children, and establishing the suitability of a potential cohort for HIV vaccine trials in Tanzania. In a field evaluation of three alternative methods for quantification of T-lymphocyte subsets, we found high overall correlation coefficients (r>0.9) of FACScount and Dynabeads CD4+ and CD8+ T-lymphocyte counts with those of flow cytometry. A lower correlation (r=0.631) was obtained for TRAx CD4 ELISA counts. Therefore, FACScount and Dynabeads methods provide alternatives to flow cytometry for the enumeration of T-lymphocyte subsets in laboratories with limited facilities. A modified heat-denatured p24 antigen assay, which is simpler and cheaper than HIV DNA PCR tests, was shown to have a high sensitivity (98.7%, 123/125) for early diagnosis of HIV-1 infection in infants. We also showed that p24 antigenemia was highly predictive of mother -to - child transmission of HIV-1. We utilized the assay to confirm the HIV-1 infection status of children below 18 months of age in a study among children (aged 1month-8yrs) hospitalized at Muhimbili Medical Centre. The overall prevalence of HIV-1 infection among the 2015 children included in the study was 19.2%. We compared the performance of several in-house nested PCR systems to that of the Amplicor (Roche) HIV-1 PCR kit in the detection of HIV-1 DNA in Tanzanian blood samples prepared by the ficoll-isopaque (FIP) centrifugation and the Amplicor PCR sample preparation methods. Samples prepared by the Amplicor method were found to be more suitable for PCR than those prepared by the FIP method. A sensitivity of 100% was achieved by combining two in-house primer sets. The sensitivity of the standard Amplicor HIV-1 PCR kit was 59%, whereas that of a modified Amplicor HIV-1 PCR test was 98%. We further compared the performance of a prototype Roche Amplicor version 1.5 PCR test with that of the standard Amplicor PCR test for the detection of HIV-1 DNA in blood samples from asymptomatic HIV-seropositive Tanzanians. The sensitivities of the Amplicor 1.5 PCR and the standard PCR assays were 99.1% (105/106) and 97% (99/102) respectively. Specificity was 100% for both assays. HIV-1 subtyping by heteroduplex mobility assay of 101 samples showed that 47% were subtype A, 30% subtype C, 20% subtype D and 3% were indeterminate. In the standard assay, a statistically significantly higher proportion of subtype A samples had a low level of reactivity compared with the subtypes C and D samples while in the prototype assay all three subtypes showed a high level of reactivity. Therefore, the Amplicor version 1.5 PCR is suitable for the detection of HIV-1 DNA in samples from geographic areas where HIV-1 subtypes A, C and D are prevalent. As part of preparations for possible future HIV vaccine trials in Tanzania, we determined the prevalence and incidence of HIV-1 infection, active syphilis and their associated factors in a cohort of police officers in Dar es Salaam. The overall HIV-1 seroprevalence at recruitment was 13.8% (378/2733). The overall HIV-1 incidence was 19.9/1000 person years at risk (PYAR); 19.6/1000 PYAR for males and 22.4/1000 PYAR for females. The overall prevalence and incidence of active syphilis were 3.1% (88/2850) and 8.6/100 (26/3149) person years, respectively. There was high risk sexual practice among the police officers, especially males. From these findings, the police officers cohort was considered to be a suitable population group for HIV vaccine trials

Abstracts of Tanzania Health Summit 2020

This book contains the abstracts of the papers/posters presented at the Tanzania Health Summit 2020 (THS-2020) Organized by the Ministry of Health Community Development, Gender, Elderly and Children (MoHCDGEC); President Office Regional Administration and Local Government (PORALG); Ministry of Health, Social Welfare, Elderly, Gender, and Children Zanzibar; Association of Private Health Facilities in Tanzania (APHFTA); National Muslim Council of Tanzania (BAKWATA); Christian Social Services Commission (CSSC); & Tindwa Medical and Health Services (TMHS) held on 25–26 November 2020. The Tanzania Health Summit is the annual largest healthcare platform in Tanzania that attracts more than 1000 participants, national and international experts, from policymakers, health researchers, public health professionals, health insurers, medical doctors, nurses, pharmacists, private health investors, supply chain experts, and the civil society. During the three-day summit, stakeholders and decision-makers from every field in healthcare work together to find solutions to the country’s and regional health challenges and set the agenda for a healthier future. Summit Title: Tanzania Health SummitSummit Acronym: THS-2020Summit Date: 25–26 November 2020Summit Location: St. Gasper Hotel and Conference Centre in Dodoma, TanzaniaSummit Organizers: Ministry of Health Community Development, Gender, Elderly and Children (MoHCDGEC); President Office Regional Administration and Local Government (PORALG); Ministry of Health, Social Welfare, Elderly, Gender and Children Zanzibar; Association of Private Health Facilities in Tanzania (APHFTA); National Muslim Council of Tanzania (BAKWATA); Christian Social Services Commission (CSSC); & Tindwa Medical and Health Services (TMHS)