The Value of Site Preparedness Studies for Future Implementation of Phase 2/IIb/III HIV Prevention Trials

Mocan, Mehmet Cem; Bozkurt, Banu; Orhan, Dıclehan; Kuzey, Gamze Mocan; İrkeç, Murat

doi:10.1097/qai.0b013e31815c71f7

Cited by 71 publications

(56 citation statements)

References 13 publications

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“…In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 and low‐income (nine studies; 8.3%) 101, 102, 103, 104, 105, 106, 107, 108, 109 countries. The location of stakeholder engagement could not be discerned in six studies (5.6%) 110, 111, 112, 113, 114, 115, and fifteen studies (13.9%) 16, 24, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128 conducted stakeholder engagement in multiple countries at different income levels.…”

Section: Resultsmentioning

confidence: 99%

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

Day

Blumberg

et al. 2018

J Intern AIDS Soc

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IntroductionStakeholder engagement is an essential component of HIV clinical trials. We define stakeholder engagement as an input by individuals or groups with an interest in HIV clinical trials to inform the design or conduct of said trials. Despite its value, stakeholder engagement to inform HIV clinical trials has not been rigorously examined. The purpose of our systematic review is to examine stakeholder engagement for HIV clinical trials and compare it to the recommendations of the UNAIDS/AVAC Good Participatory Practice (GPP) guidelines.MethodsWe used the PRISMA checklist and identified English language studies describing stakeholder engagement to inform HIV clinical trials. Four databases (PubMed, Ovid, CINAHL and Web of Science) and six journals were searched, with additional studies identified using handsearching and expert input. Two independent reviewers examined citations, abstracts and full texts. Data were extracted on country, engagement methods, stakeholder types and purpose of stakeholder engagement. Based on the GPP guidelines, we examined how frequently stakeholder engagement was conducted to inform clinical trial research question development, protocol development, recruitment, enrolment, follow‐up, results and dissemination.Results and discussionOf the 917 citations identified, 108 studies were included in the analysis. Forty‐eight studies (44.4%) described stakeholder engagement in high‐income countries, thirty (27.8%) in middle‐income countries and nine (8.3%) in low‐income countries. Fourteen methods for stakeholder engagement were identified, including individual (e.g. interviews) and group (e.g. community advisory boards) strategies. Thirty‐five types of stakeholders were engaged, with approximately half of the studies (60; 55.6%) engaging HIV‐affected community stakeholders (e.g. people living with HIV, at‐risk or related populations of interest). We observed greater frequency of stakeholder engagement to inform protocol development (49 studies; 45.4%) and trial recruitment (47 studies; 43.5%). Fewer studies described stakeholder engagement to inform post‐trial processes related to trial results (3; 2.8%) and dissemination (11; 10.2%).ConclusionsOur findings identify important directions for future stakeholder engagement research and suggestions for policy. Most notably, we found that stakeholder engagement was more frequently conducted to inform early stages of HIV clinical trials compared to later stages. In order to meet recommendations established in the GPP guidelines, greater stakeholder engagement across all clinical trial stages is needed.

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Section: Resultsmentioning

confidence: 99%

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

Day

Blumberg

et al. 2018

J Intern AIDS Soc

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“…South Africa and many southern African countries continue to experience similar high HIV incidence rates. Longitudinal studies among women in South Africa have shown HIV incidence rates of 6.6, 8.5 and 6.5 per 100 wy particularly amongst young women in the province of KwaZulu–Natal (6, 10, 29). Among pregnant women from the same region, HIV incidence was 10.7 per 100 wy (30).…”

Section: Discussionmentioning

confidence: 99%

Risk Factors for HIV Acquisition in High Risk Women in a Generalised Epidemic Setting

et al. 2015

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In South Africa young women bear a disproportionate burden of HIV infection however, risk factors for HIV acquisition are not fully understood in this setting. In a cohort of 245 women, we used proportional hazard regression analysis to examine the association of demographic, clinical and behavioural characteristics with HIV acquisition. The overall HIV incidence rate (IR) was 7.20 per 100 women years (wy), 95% Confidence Interval (CI) 4.50–9.80]. Women 18–24 years had the highest HIV incidence [IR 13.20 per 100 wy, 95% CI 6.59–23.62] and were almost three times more likely to acquire HIV compared to women 25 years and older [adjusted Hazard Ratio (aHR) 2.61, 95% CI 1.05–6.47]. Similarly, women in relationships with multiple sex partners had more than twice the risk of acquiring HIV when compared to women who had no partner or who had a husband or stable partner (aHR 2.47, 95% CI 0.98–6.26). HIV prevention programmes must address young women's vulnerability and sex partner reduction in this setting.

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“…This analysis includes women who participated in three multi-centre trials at sites in KZN: Methods for Improving Reproductive Health in Africa (MIRA) trial [12], conducted in rural Umkomaas and Botha’s Hill; Microbicides Development Programme (MDP) Feasibility study in preparation for Phase III Microbicide Trials [13], in semi-rural Tongaat and Verulam; and HIV Prevention Trials Network (HPTN) Site Preparedness study (HPTN 055) for future implementation of Phase 2/IIb/III HIV Prevention Studies [14], in an urban area in Durban and in a rural district of Hlabisa. Study populations were described elsewhere in detail [12-14].…”

Section: Methodsmentioning

confidence: 99%

“…Study procedures were described in detail elsewhere [12-14]. Main inclusion criteria were similar in all three studies, and briefly included being sexually active; HIV negative at screening; not pregnant, willing to provide written consent, and follow study procedures.…”

Section: Methodsmentioning

confidence: 99%

High prevalence and incidence of sexually transmitted infections among women living in Kwazulu-Natal, South Africa

et al. 2014

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Background and objectivesSexually transmitted infections (STIs) contribute largely to the burden of health in South Africa and are recognized as major contributors to the human immunodeficiency virus (HIV) epidemic. Young women are particularly vulnerable to STIs. The purpose of this secondary analysis was to examine the risk factors associated with prevalent and incident STIs among women who had participated in three clinical trials.MethodsA total of 5,748 women were screened and 2293 sexually active, HIV negative, non-pregnant women were enrolled in three clinical trials in Kwazulu-Natal, South Africa. The prevalence of individual STIs Chlamydia trachomatis (CT), Neisseria gonorrhea (NG), syphilis, and Trichomonas vaginalis (TV) was assessed at screening; and incident infections were evaluated over a 24 month period.ResultsOverall, the combined study population of all three trials had a median age of 28 years (inter-quartile range (IQR):22–37), and a median duration of follow-up of 12 months. Prevalence of STIs (CT, NG, TV, or syphilis) was 13% at screening. The STI incidence was estimated to be 20/100 women years. Younger women (<25 years, p < 0.001), women who were unmarried (p < 0.001) and non-cohabiting women (p < 0.001) were shown to be at highest risk for incident STIs.ConclusionsThese results confirm the extremely high prevalence and incidence of STIs among women living in rural and urban communities of KwaZulu-Natal, South Africa, where the HIV epidemic is also particularly severe. These findings strongly suggest an urgent need to allocate resources for STI and HIV prevention that mainly target younger women.Trial registrationClinical Trials.gov, NCT00121459.

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The Value of Site Preparedness Studies for Future Implementation of Phase 2/IIb/III HIV Prevention Trials

Cited by 71 publications

References 13 publications

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

Risk Factors for HIV Acquisition in High Risk Women in a Generalised Epidemic Setting

High prevalence and incidence of sexually transmitted infections among women living in Kwazulu-Natal, South Africa

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