Safety and Acceptability of the Candidate Microbicide Carraguard in Thai Women

Kilmarx, Peter H.; Wijgert, Janneke van de; Chaikummao, Supaporn; Jones, Heidi E.; Limpakarnjanarat, Khanchit; Friedland, Barbara; Karon, John M.; Manopaiboon, Chomnad; Srivirojana, Nucharee; Yanpaisarn, Somboonsak; Supawitkul, Somsak; Young, Nancy L.; Mock, Philip A.; Blanchard, Kelly; Mastro, Timothy D.

doi:10.1097/01.qai.0000243056.59860.c1

Cited by 82 publications

(53 citation statements)

References 17 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 informHIVclinical 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 informHIVclinical trials: a systematic review of the evidence

Day

Blumberg

et al. 2018

J Intern AIDS Soc

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“…Carrageenans have shown antiviral and antibacterial properties against HIV, herpes simplex virus-type 2 (HSV-2) and Neisseria gonorrhoeae [1][2][3][4][5][6]. The safety of vaginal administration has also been confirmed by laboratory and Phase 1 and 2 clinical studies [5,[7][8][9]. Furthermore, a large Phase III effectiveness trial is currently underway in South Africa.…”

Section: Introductionmentioning

confidence: 99%

Effect of mifepristone on endometrial matrix metalloproteinase expression and leukocyte abundance in new medroxyprogesterone acetate users

Felix

Yang

et al. 2007

Contraception

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Objective-The study was conducted to evaluate the effect of Carraguard vaginal gel containing 0.75 mg of levonorgestrel (CARRA/LNG gel) administered in a single dose at different stages of follicle development, over subsequent follicle rupture and hormonal levels.Method-Randomized, blinded, cross-over study comparing the effects of a single administration of CARRA/LNG gel or Carraguard (CARRA) gel. Twenty-four healthy women were enrolled in two centers. The gels were administered when the follicle had reached diameters of 12-14, 15-17 and ≥18 mm in 8 women each. Volunteers were followed for one treatment, one washout cycle and a second treatment cycle. Follicle rupture or non-rupture was assessed by transvaginal ultrasound. LH, estradiol and progesterone levels were measured daily for the 5 days following treatment, and 3 times per week until menses.Results-No follicular rupture within the 5-day period following administration was observed in 74% and 30% of the CARRA/LNG and CARRA gel treatment cycles, respectively, while ovulation was documented in 4% and 61%, respectively. The overall proportion of cycles with lack of follicular rupture or ovulatory dysfunction (follicle rupture preceded by an inadequate LH surge) was 96% for CARRA/LNG and 39% in the CARRA gel cycles.Conclusion-Single vaginal administration of 0.75 mg levonorgestrel in CARRA gel in the late follicular phase, is effective for interfering with the ovulatory process.

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“…Findings from pregnancy outcomes among women conceiving on PrEP and/or microbicides during trials have provided little reason for concern; however, in all these trials study drug has been stopped once pregnancy was detected. [47][48][49][50][51][52][53] Overall, these evidence gaps reflect the only recently expanded HIV prevention options for HIV-affected couples, but also reflect years of stigma, discrimination and lack of legal protection for the reproductive rights of HIV-affected couples.…”

Section: Resultsmentioning

confidence: 99%

Fertility-related research needs among women at the margins

Schwartz¹,

Baral

2015

Reproductive Health Matters

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Fertility-related research encompasses fertility intentions, preconception care, research amongst pregnant women, and post-partum outcomes of mothers and children. However, some women remain underrepresented within this domain of study. Women frequently missing within fertility-related research include those who are already the most vulnerable to health disparities, including female sex workers, lesbian, gay, bisexual, and transgender women, women living with HIV, and women who use drugs. Yet characterization of the needs of these women is important, given their unique fertility-related concerns, including risks and barriers to care emanating from social stigmas and discrimination. This synthesis provides an overview of fertility-related evidence, highlighting where there are clear research gaps among marginalized women and the potential implications of these data shortfalls. Overall, research among marginalized women to date has addressed pregnancy prevention and in some cases fertility intentions, but the majority of studies have focused on postconception pregnancy safety and the well-being of the child. However, among female sex workers specifically, data on pregnancy safety and the well-being of the child are largely unavailable. Within each marginalized group, preconception care and effectiveness of conception methods are consistently understudied. Ultimately, the absence of epidemiologic, clinical and programmatic evidence limits the availability and quality of reproductive health services for all women and prevents social action to address these gaps.

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Safety and Acceptability of the Candidate Microbicide Carraguard in Thai Women

Abstract: Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa.

Cited by 82 publications

References 17 publications

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

Effect of mifepristone on endometrial matrix metalloproteinase expression and leukocyte abundance in new medroxyprogesterone acetate users

Fertility-related research needs among women at the margins

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