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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

Patterns of sexually transmitted infections in adolescents and youth in Dar es Salaam, Tanzania

BACKGROUND: Syndromic management of STIs has been advocated as simplified and cheap approach. Youth have been reported to be at increased risk of acquiring STIs which can facilitate HIV transmission. We have investigated the relationship between the syndromic management and specific aetiology diagnosis and its relationship with HIV infection and health seeking behaviour among youth attending a reproductive health clinic in Dar es Salaam, Tanzania. METHODS: Between September 1998 and February 1999 among 1895 adolescents and youth below 25 years seen in the clinic 199 (10.5%) were randomly selected and consented to participate in the study. A standard questionnaire was administered. Blood and vaginal or urethral specimens were taken and investigated for STI causative agents. RESULTS: Among a total of 199 studied adolescents and youth 22.6 % were teenagers, with fewer females 17.8% than males; 27.5% (p < 0.018). 20.8% of the females compared to 11.5% in males were HIV infected. Genital discharge was the most common complaint which was reported in 54.1% of male and 63.4 % of female patients. All males with gonorrhoea and four out of five with Chlamydia were given appropriate treatment with syndromic management, while 28% women with gonorrhoea or Chlamydia received appropriate treatment by syndromic management. All patients found with active syphilis by serology had not complained of genital ulcers and would not have been assigned to syndromic treatment for syphilis at the initial visit. CONCLUSION: The burden of STIs in this youth population is large indicating that youth are at increased risk of STIs and will certainly require youth friendly clinics. There is a need to refine the current syndromic management guidelines

A qualitative evaluation of volunteers' experiences in a phase I/II HIV vaccine trial in Tanzania

Evaluating experiences of volunteers in an HIV vaccine trial will be useful for the conduct of future trials. The purpose of this study among volunteers who participated in a phase I/II HIV vaccine trial in Dar es Salaam, Tanzania was to assess what characterized their experiences during the trial. We conducted four focus group discussions with 35 out of the 60 individuals (women and men) after the five scheduled vaccinations. An interpretive description approach was applied to data analysis. As a result of the trial interventions, both men and women gained confidence in their own abilities to have safer, less risky sexual behaviour. The participants experienced the trial as a way of accessing free [insured] medical services. Most of the men said they had gone from self-medication to professional medical consultation. Despite these benefits, the participants faced various challenges during the trial. Such challenges included mistrust of the trial shown by health care providers who were not connected to the trial and discouragement from friends, colleagues and family members who questioned the safety of the trial. However, they managed to cope with these doubts by using both personal and trial related interventions. We found that during the phase I/II HIV vaccine trial, participants had both the opportunities and the ability to cope with the doubts from the surrounding community. Follow up visits enhanced the opportunities and individuals' abilities to cope with the doubts during the trial. Understanding this discourse may be useful for the trial implementers when designing future trials.\ud \ud \ud \u

Experiences of social harm and changes in sexual practices among volunteers who had completed a phase I/II HIV vaccine trial employing HIV-1 DNA priming and HIV-1 MVA boosting in Dar es Salaam, Tanzania.

BACKGROUND: Volunteers in phase I/II HIV vaccine trials are assumed to be at low risk of acquiring HIV infection and are expected to have normal lives in the community. However, during participation in the trials, volunteers may encounter social harm and changes in their sexual behaviours. The current study aimed to study persistence of social harm and changes in sexual practices over time among phase I/II HIV vaccine immunogenicity (HIVIS03) trial volunteers in Dar es Salaam, Tanzania. METHODS AND RESULTS: A descriptive prospective cohort study was conducted among 33 out of 60 volunteers of HIVIS03 trial in Dar es Salaam, Tanzania, who had received three HIV-1 DNA injections boosted with two HIV-1 MVA doses. A structured interview was administered to collect data. Analysis was carried out using SPSS and McNemars' chi-square (χ2) was used to test the association within-subjects. Participants reported experiencing negative comments from their colleagues about the trial; but such comments were less severe during the second follow up visits (χ2 = 8.72; P<0.001). Most of the comments were associated with discrimination (χ2 = 26.72; P<0.001), stigma (χ2 = 6.06; P<0.05), and mistrust towards the HIV vaccine trial (χ2 = 4.9; P<0.05). Having a regular sexual partner other than spouse or cohabitant declined over the two follow-up periods (χ2 = 4.45; P<0.05). CONCLUSION: Participants in the phase I/II HIV vaccine trial were likely to face negative comments from relatives and colleagues after the end of the trial, but those comments decreased over time. In this study, the inherent sexual practice of having extra sexual partners other than spouse declined over time. Therefore, prolonged counselling and support appears important to minimize risky sexual behaviour among volunteers after participation in HIV Vaccine trials

Reasons for declining to enroll in a phase I and II HIV vaccine trial after randomization among eligible volunteers in Dar es Salaam, Tanzania.

BACKGROUND: Recruitment, enrollment and retention of volunteers in an HIV vaccine trial is important in the efforts to ultimately develop a vaccine that can prevent new HIV infections. Following recruitment, some randomized individuals decline to be enrolled in an HIV vaccine trial. The reasons for such a decision are not well known. This article describes why individuals who were randomized in a phase I and II HIV vaccine trial in Dar es Salaam, Tanzania declined to be enrolled. METHODS: Face-to-face interviews were conducted with 14 individuals (7 men and 7 women). Repeated readings of the 14 interview transcripts to look for reasons for declining to enroll in the trial were performed. Data was analyzed using the content analysis approach. RESULTS: Informants expressed fear of the outcome of an experimental HIV vaccine in their lives. Unlike women, some men were concerned over the effect of the vaccine on their reproduction intentions. Women were concerned about the unknown effects of the vaccine in their bodies. Also, to a large extent, informants faced resistance from significant others such as fiancées, parents, relatives, and friends. Women were influenced by their potential intimate sexual partners; men were forbidden by their parents, and mothers had the most influential opinion. CONCLUSIONS: Fear of the negative outcome of an experimental vaccine and resistance from significant others are the main reasons for declining to enroll in the HIV vaccine trial among eligible volunteers after randomization. The resistance from the significant others provides valuable guidance for designing future trials in Tanzania; for example, expanding the HIV vaccine trial education to the general population from the onset of the trial design

HIV-1 Infection Prevalence and Incidence Trends in Areas of Contrasting Levels of Infection in the Kagera Region, Tanzania, 1987-2000

This study aimed at assessing the extent to which decline in HIV infection prevalence reflects decline in incidence in 3 areas with contrasting initial exposure to the HIV epidemic in the Kagera region of Tanzania. A population sample was recruited for the baseline study in 1987 through a multistage cluster sampling technique to determine HIV prevalence. Seronegative individuals identified in the baseline and subsequent studies were followed up for 3 years to yield trends in incidence that were compared for the 3 areas. The overall age-adjusted HIV-1 prevalence in the high-prevalence area of Bukoba urban declined significantly from 24.2% in 1987 to 18.2% in 1993 and later to 13.3% in 1996 (P = 0.0001). In the medium-prevalence area of Muleba, overall age-adjusted prevalence declined significantly from 10.0% in 1987 to 6.8% in 1996 and later to 4.3% in 1999 (P = 0.0003), whereas in the low-prevalence area of Karagwe the prevalence declined from 4.5% in 1987 to 2.6% in 1999 (P = 0.01). In all 3 areas, the most significant decline was consistently observed among women in the age group 15-24 years. No age group exhibited a significant upward prevalence trend. The HIV-1 incidence for Bukoba urban declined from 47.5 to 9.1 per 1000 person-years of observation in 1989 and 1996, respectively, whereas in Muleba it decreased from 8.2 to 3.9 in 1989 and 2000, respectively. Sex-specific estimates indicated a significant decline among women in the high-prevalence area of Bukoba urban from 51.5 to 9.2 per 1000 person-years at risk (P = 0.001). It is concluded that the HIV-1 epidemic in Kagera is on the decrease as reflected by the decline in HIV-1 incidence and prevalence trends particularly among the 15-24 year olds. The decline in the 3 areas of differing magnitude implies that the HIV/AIDS epidemic may be arrested early without necessarily peaking to saturation levels

Gender aspects on HIV prevention efforts and participation in HIV vaccine trials among Police officers in Dar es Salaam, Tanzania

Abstract Background For more than three decades, Human Immunodeficiency Virus (HIV) infection and Acquired Immune Deficiency Syndrome (AIDS) continue to dominate the health agenda. In sub-Saharan African countries, women are at more risk of contracting HIV and AIDS compared with men due to biological, social, economic, socio-economic and cultural factors. Women in the uniformed services may be more vulnerable to HIV/AIDS because of their work context, mobility, age and other factors that expose them to a higher risk of infection than women in the general population. This article describes gender dimensions, motives and challenges towards HIV prevention amongst Police officers (POs) in Dar es Salaam, Tanzania. Methods This was a descriptive qualitative study conducted at Police stations in Dar es Salaam, Tanzania. Fifteen in-depth interviews were conducted on POs; seven men, and eight women. Content analysis approach was used to analyze data. Results Participants’ self-descriptions shed light on gender differences in relation to self -perceptions, job contexts, sexual relationships and HIV prevention. Both men and women perceived themselves as role models, and believed that the surrounding community perceived the same. Safe sexual behavior appeared crucial to avoid undesirable health outcomes. Risky sexual practices were considered avoidable. Under unavoidable sexual temptations, women in particular would be keen to avoid risky sexual practices. Some participants expressed positive views towards condoms use during extra-marital sexual relationships, while others had negative opinions. Early phases of HIV vaccine trials appeared to gain support from sexual partners. However, condom use during phase I/II HIV vaccine trials was deemed as difficult. Support from the spouse was reported to influence condom use outside the wedlock. However, religious beliefs, socio-cultural issues and individual reasons were perceived as difficulties to promote condoms use. Conclusions These findings increase understanding of gender differences and context specific efforts towards HIV prevention. Individuals’ assertiveness against risky sexual practices and the intention to participate in HIV vaccine trials to develop an effective vaccine are worth noting. Nevertheless, uncertainties towards condoms use underscore the importance of condoms’ marketing particularly in extra marital sexual relationships and during early HIV vaccine trials