Count in the young people : HIV vaccine trial participation in Tanzania

Background: For nearly four decades, HIV infection has raged across the world; leaving devastation in its wake particularly in sub-Saharan Africa. Even though the use of antiretroviral (ARV) drugs has significantly contributed to lessening HIV/AIDS related morbidity and mortality, their efficacy has had a limited outcome on the cure and prevention of both old and new HIV infections. Like many viral diseases, an effective HIV vaccine is considered the cornerstone for ending the HIV epidemic. The involvement of young people in preventive HIV vaccine clinical trials is fundamental as they are unduly affected by the HIV burden. Whilst new vaccine models continue to be tested for safety, immunogenicity and efficacy, only a few young people join such innovative clinical interventions; highlighting an evolving need for understanding the intricacies of partaking in clinical HIV vaccine trials. Aim: The overall aim for this thesis was to increase knowledge of factors contributing to recruitment and participation of young people in preventive HIV vaccine trials. Methods: The thesis encompassed four studies using both qualitative and quantitative methods. Data collection for cross sectional study I was done among 450 youth using questionnaires to assess factors contributing to their willingness to participate in an HIV vaccine trial. Study II used seven focus group discussions to elicit the influence and opinions of members of the community on participation in the trial. In study III, we employed respondent-driven sampling to enlist 600 young female sex workers in a cross-sectional study that assessed willingness to participate in HIV efficacy trials and risk behaviors using questionnaires. In-depth interviews were used in study IV to explore experiences of participating in HIV vaccine trials among 17 young volunteers in a phase I/II HIV vaccine trial, TaMoVac 01. Results: This thesis identified positive and negative attributes of the willingness of young people to participate in an HIV vaccine trial at several levels of ecological model. At the intrapersonal level, altruism, self-independence in decision making, being in charge of safe sex, having some knowledge of HIV vaccines and regular health check-ups were regarded as positive attributes for joining the trial whereas anxiety about fertility and HIV positivity post vaccination were identified constraints. Looking at the interpersonal level, endorsement of the trial by significant others and support of staff were features of partaking whereas fears of perceived contents of HIV vaccine and mischaracterization of sexual practices were portrayed as impediments. Last but not least, support of regulatory institutions, members of parliament, stigma, and the trial center were elements at the community/institutional level, while substance abuse, unemployment and poverty were structural factors hampering the contribution of young people to HIV vaccine trials. Conclusion: Youth showed readiness to participate in phase IIa HIV vaccine trial. For most young people, the decision to participate in vaccine trials largely depend on support of members of the community. In contrast, for high-risk young women, this decision largely be their own. Some factors like altruism, support from members of the community and, perceived personal benefit served as positive attributes to participation. Despite such readiness, fertility issues, stigma, poverty were perceived as hurdles needed to be resolved by different stakeholders on individual, community and societal levels for successful participation

Factors that Influence the Willingness of Young Adults in Dar es Salaam, Tanzania, to Participate in Phase I/II HIV Vaccine Trials.

HIV/AIDS continues to destroy the lives of young people especially in low-income countries. The inclusion of youths in HIV vaccine trials is of utmost importance in obtaining an effective vaccine that is acceptable to them.\ud To characterize the willingness of young adults in Tanzania to participate in an HIV vaccine trial and the factors that influence this willingness. Four hundred and fifty young adults who visited a youth-friendly Infectious Diseases Clinic (IDC) from February 2012 to September 2012 completed a self-administered questionnaire concerning sociodemographic information, their knowledge about and perception of HIV vaccine studies, and the availability of social support. Of our participants, 50.6% expressed willingness to participate in HIV vaccine trials, and this willingness was positively correlated with having some knowledge about HIV vaccine studies (AOR, 2.2; 95% CI: 1.4-3.4), a positive perception toward such studies (AOR, 2.3; 95% CI: 1.5-3.6), having a relationship with someone who could help them make a decision (AOR, 2.5; 95% CI: 1.3-4.9), and age at the time of sexual debut (AOR, 2.6; 95% CI 1.0-6.7) for 15- to 19-year-olds and (AOR, 2.7; 95% CI 1.0-7.1) for older participants. The participants exhibited a moderate willingness to participate in HIV vaccine trials, which was associated with a positive perception of and some knowledge about such trials, having a relationship with someone who might influence their decision as well as age at time of sexual debut. More efforts should be made to inform the youths about specific HIV vaccine trials and related matters, as well as to engage significant others in the decision-making process

Quality Of Antenatal Care In Rural Southern Tanzania: A Reality Check.

Counselling on the danger signs of unpredictable obstetric complications and the appropriate management of such complications are crucial in reducing maternal mortality. The objectives of this study were to identify gaps in the provision of ANC services and knowledge of danger signs as well as the quality of care women receive in case of complications. The study took place in the Rufiji District of Tanzania in 2008 and was conducted in seven health facilities. The study used (1) observations from 63 antenatal care (ANC) sessions evaluated with an ANC checklist, (2) self-assessments of 11 Health workers, (3) interviews with 28 pregnant women and (4) follow-up of 12 women hospitalized for pregnancy-related conditions.Blood pressure measurements and abdominal examinations were common during ANC visits while urine testing for albumin or sugar or haemoglobin levels was rare which was often explained as due to a lack of supplies. The reasons for measuring blood pressure or abdominal examinations were usually not explained to the women. Only 15/28 (54%) women were able to mention at least one obstetric danger sign requiring medical attention. The outcomes of ten complicated cases were five stillbirths and three maternal complications. There was a considerable delay in first contact with a health professional or the start of timely interventions including checking vital signs, using a partograph, and detailed record keeping. Linking danger signs to clinical and laboratory examination results during ANC with the appropriate follow up and avoiding delays in emergency obstetric care are crucial to the delivery of coordinated, effective care interventions

The Influence of Community Members on Participation by Youth in an HIV Vaccine Trial in Tanzania.

In sub-Saharan Africa, the burden of HIV is high among young people and it is of the utmost importance that they be recruited into vaccination trials. Since community members influence the willingness of young people to participate in the vaccination trials, ascertaining their opinions is essential to overcoming barriers to such participation. Here, in seven focus group discussions we explored the views of 44 community members identified as someone they felt close by youth in Tanzania. The transcripts of these discussions were examined using content analysis. Our participants expressed that community members would be directly involved in the decisions of young people about whether or not to participate in an HIV vaccine trial. In general, they felt that community members would provide social support for youth during the trial and perceived that youth might have misconceptions concerning the vaccine and trial process. The participants pointed out structural factors such as substance use, poverty, stigma and unemployment that are barriers to participation. In conclusion, involvement of community members could be an integral part of the recruitment and retention of young people in HIV vaccine trials in Tanzania

Quality of antenatal care in rural southern Tanzania: a reality check

Abstract Background Counselling on the danger signs of unpredictable obstetric complications and the appropriate management of such complications are crucial in reducing maternal mortality. The objectives of this study were to identify gaps in the provision of ANC services and knowledge of danger signs as well as the quality of care women receive in case of complications. Findings The study took place in the Rufiji District of Tanzania in 2008 and was conducted in seven health facilities. The study used (1) observations from 63 antenatal care (ANC) sessions evaluated with an ANC checklist, (2) self-assessments of 11 Health workers, (3) interviews with 28 pregnant women and (4) follow-up of 12 women hospitalized for pregnancy-related conditions. Blood pressure measurements and abdominal examinations were common during ANC visits while urine testing for albumin or sugar or haemoglobin levels was rare which was often explained as due to a lack of supplies. The reasons for measuring blood pressure or abdominal examinations were usually not explained to the women. Only 15/28 (54%) women were able to mention at least one obstetric danger sign requiring medical attention. The outcomes of ten complicated cases were five stillbirths and three maternal complications. There was a considerable delay in first contact with a health professional or the start of timely interventions including checking vital signs, using a partograph, and detailed record keeping. Conclusion Linking danger signs to clinical and laboratory examination results during ANC with the appropriate follow up and avoiding delays in emergency obstetric care are crucial to the delivery of coordinated, effective care interventions.</p

Post-HIV vaccine trials’ misperception and associated factors among participating communities in Dar es Salaam, Tanzania

&nbsp;Background: Despite the successful conduct of three Phase I/II HIV vaccine trials in Dar es Salaam, Tanzania, misperception around the trials has been reported. In this study, misperception means incorrect understanding that in Phase I/II HIV vaccine trial, the researchers infected the volunteers with HIV. We describe the magnitude of misperception around HIV vaccine trials and associated factors among participating communities in Dar es Salaam, Tanzania. Methods: We conducted a cross-sectional study that included 605 respondents aged ³18 years from the communities that participated in Phase I/II HIV vaccine trials. These communities comprised of youths, Police and Prison officers. Respondents were interviewed using a pre-tested questionnaire on socio-demographic characteristics, HIV knowledge, and responses to HIV vaccine trial related questions. Results: Of the 605 respondents, 156 (26%) had misperception that the researchers infected the volunteers with HIV during the trials, while 58% weren’t sure whether the researchers infected the volunteers with the HIV or not. Awareness about progress in HIV vaccine development (adjusted risk ratio (RR)=1.50; 95% CI=1.11 – 2.04), participation in an HIV vaccine sensitization meeting (adjusted RR=1.50; 95% CI=1.14-1.97) and advanced secondary education (adjusted RR=1.92; 95% CI=1.19 – 3.09) were associated with an increased likelihood of having the misperception that researchers infected the volunteers. Nevertheless, the majority (94.5%) of respondents showed a willingness to know more about ongoing HIV vaccine studies while about 44.3% had reservations of taking part in HIV vaccine trials due to fear of getting HIV from the vaccine. Conclusions: The misperception that researchers infected volunteers with HIV in Phase I/II trial is significant and was associated with respondents’ awareness about HIV vaccine development, participation in sensitization meetings and advanced education. Partial knowledge about HIV vaccine trials was of note. Future HIV vaccine trials should strive to address the knowledge gap

Early risk assessment in paediatric and adult household contacts of confirmed tuberculosis cases by novel diagnostic tests (ERASE-TB): protocol for a prospective, non-interventional, longitudinal, multicountry cohort study.

INTRODUCTION: The WHO End-TB Strategy calls for the development of novel diagnostics to detect tuberculosis (TB) earlier and more accurately. Better diagnostics, together with tools to predict disease progression, are critical for achieving WHO End-TB targets. The Early Risk Assessment in TB Contacts by new diagnoStic tEsts (ERASE-TB) study aims to evaluate novel diagnostics and testing algorithms for early TB diagnosis and accurate prediction of disease progression among household contacts (HHCs) exposed to confirmed index cases in Mozambique, Tanzania and Zimbabwe. METHODS AND ANALYSIS: A total of 2100 HHCs (aged ≥10 years) of adults with microbiologically-confirmed pulmonary TB will be recruited and followed up at 6-month intervals for 18–24 months. At each time point, a WHO symptom screen and digital chest radiograph (dCXR) will be performed, and blood and urine samples will be collected. Individuals screening positive (WHO symptom screen or dCXR) will be requested to provide sputum for Xpert MTB/Rif Ultra. At baseline, HHCs will also be screened for HIV, diabetes (HbA1c), chronic lung disease (spirometry), hypertension and anaemia. Study outcomes will be coprevalent TB (diagnosed at enrolment), incident TB (diagnosed during follow-up) or no TB at completion of follow-up. Novel diagnostics will be validated using fresh and biobanked samples with a nested case–control design. Cases are defined as HHCs diagnosed with TB (for early diagnosis) or with incident TB (for prediction of progression) and will be matched by age, sex and country to HHCs who remain healthy (controls). Statistical analyses will include assessment of diagnostic accuracy by constructing receiver operating curves and calculation of sensitivity and specificity ETHICS AND DISSEMINATION: ERASE-TB has been approved by regulatory and ethical committees in each African country and by each partner organisation. Consent, with additional assent for participants &lt;18 years, is voluntary. Attestation by impartial witnesses is sought in case of illiteracy. Confidentiality of participants is being maintained throughout. Study findings will be presented at scientific conferences and published in peer-reviewed international journals. TRIAL REGISTRATION NUMBER: NCT0478125