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

Abstract

BackgroundEventual 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.MethodsIn 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.ResultsOut 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.ConclusionIn 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.Trial registration numbersISRCTN90053831 ISRNCT01132976 and ATMR2009040001075080

The willingness to participate in biomedical research involving human beings in low‐ and middle‐income countries: a systematic review

“…Lack of social support was mentioned as a reason for non‐participation 23 times , ranked in the top three eleven times , and given as the top reason three times . Lack of social support was found to be ranked higher (third) for research being conducted in Asia, involving HIV and women, whilst playing a smaller role in the regions of Sub‐Saharan Africa, North Africa and the Middle East and Eastern Europe.…”

“…Additional reasons given for non‐participation were costs , cultural insensitivity , fear of false‐positive test results after participation in HIV research , fear of knowledge of health status , insufficient compensation , invasive procedures, lack of interest , lack of clarity , not willing to comply to terms of research , no perceived need , feeling overwhelmed , placebo concerns , having had a previous negative experience , not wishing to be re‐contacted , feeling tempted to unsafe behaviour , lack of perceived benefit , effect on lifestyle , worsening medical condition, and having a lack of knowledge about research .…”

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“…Encouragement from family and friends was shown to be important in successful recruitment and retention of study volunteers [46, 47]. Important motivators for participation included an altruistic desire to contribute to protection from HIV, prevention, eliminating the spread of HIV/AIDS, and improved access to health care services and counseling [48, 49].…”

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