This is a single-center, two-part, Phase 1 study to evaluate the pharmacokinetics (PK) of ENG, removability, safety, and tolerability of Casea S pellets inserted subdermally in healthy women of reproductive age. The goal is to select for further investigation a dose of Casea S that is both safe and has a PK profile consistent with contraceptive protection for at least 78 weeks.

Start Date13 Dec 2023

Sponsor / Collaborator

FHI 360

[+1]

NCT06478147

/ Active, not recruitingNot ApplicableIIT

Effect of a Novel Protein Ingredient Combined With Oral Nutritional Supplement on Appetite in Older Adults

Reduced appetite can occur with ageing and is linked to a higher risk of undernutrition, poorer physical function and becoming frail. Strategies to increase appetite are needed to improve healthy ageing. This study follows on from previous work which has found a novel ingredient in whey protein (derived from whole milk) that may help to increase appetite and energy intake. This study will compare the effects of the ingredient added to an oral nutritional supplement (ONS) versus the ONS alone versus the ingredient dissolved in water on appetite in older adults. By studying this nutrition supplement in older adults, this will help to provide greater information on possible nutrition strategies to improve healthy ageing.

Start Date02 Dec 2023

Sponsor / Collaborator

University College Dublin

[+1]

NCT05233956

/ RecruitingNot ApplicableIIT

Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya: an Open Label Randomized Trial to Compare With an Oral Contraceptive Regimen That Provides Supplemental Ferrous Fumarate Tablets

Women with mild/moderate anemia who are seeking contraception will be randomized to a levonorgestrel (LNG) intrauterine system (IUS) or an LNG/ethinyl estradiol (EE)/ferrous fumarate combined oral contraceptive (COC) regimen and followed prospectively for 18 months. Approximately 600 participants will be enrolled. The primary hypothesis is that the mean change in hemoglobin concentration will be significantly higher in the group assigned to the LNG IUS compared to the group assigned to COCs

Start Date23 Oct 2023

Sponsor / Collaborator

FHI 360

[+1]

100 Clinical Results associated with FHI 360

0 Patents (Medical) associated with FHI 360

1,230

Literatures (Medical) associated with FHI 360

01 Dec 2025·Current HIV/AIDS Reports

Understanding the Drivers of CAB PrEP Uptake and Use among Women in sub-Saharan Africa to Build Demand for New PrEP Methods

Review

Author: Mungai-Barris, Zoe ; Briedenhann, Elmari ; Donaldson, Emily ; Schwartz, Katie ; Irungu, Elizabeth ; Bishopp, Casey

AbstractPurpose of ReviewAs injectable cabotegravir for pre-exposure prophylaxis (CAB PrEP) is introduced in sub-Saharan Africa, it is important to understand how behavioral drivers may influence women’s decisions around whether or not to use it.Recent FindingsFacilitating factors include prior familiarity with injections and the perceived efficacy of CAB PrEP, while barriers include a fear or dislike of needles and negative attitudes held by community members and influencers. Further research is needed to fully understand behavioral factors affecting African women’s CAB PrEP use.SummaryHIV prevention policymakers, practitioners, advocates, and clients are optimistic about CAB PrEP, predicting that this long-acting method will be popular among women in sub-Saharan Africa. However, women may also face barriers to use. Knowledge of behavioral facilitators and barriers can enhance the adaptation or development of HIV prevention communication and demand generation strategies that support informed decision-making in a multi-method market.

31 Mar 2025·Medecine tropicale et sante internationale

[Analysis of retention in care for people living with HIV in Togo: results of a survey conducted in 2021].

Article

Author: Wade, Souley ; Deku, Kodjo ; Ekouevi, Didier Koumavi ; Tchupo, Jean-Paul ; Teclessou, Julienne Noude ; Akakpo, Abla Sefako ; Adam, Zakilatou ; Pitché, Palokinam ; Dagnra, Anoumou Yawotsè

IntroductionThe aim of our study was to analyze retention in care and survival at 12, 24, and 36 months among people living with HIV (PLWH) on antiretroviral therapy (ART).MethodsThis is a retrospective cross-sectional analysis of a cohort of PLWH aged 15 years and older who started ART. Purposive sampling was used, taking into account the activities of different health centers and budgetary constraints (quantitative approach). In-depth individual interviews and focus groups were also conducted (qualitative approach).ResultsDuring the study period, 2,100 HIV-infected patients were enrolled. The median age of patients was 44 years (interquartile range (IQR) [36-51]), with a statistically significant difference according to sex (p< 0.001), with women being younger than men (42 versus 46 years). The median duration of ART was 5 years (IQR [2-8]) with no statistical difference by gender (p=0.752). At baseline, 20.5% (n=431) and 25.1% (n=509) were lost to follow-up (LTF) 90 days and 28 days after scheduled visit, respectively. There were 146 adult deaths, for a crude mortality rate of 6.9% (95% CI [5.9-8.1]). Approximately 60% of the 158 PLWH randomly selected from our LTF patients could be reached by telephone. They reported that they were still in care. Retention in care was 72.5%, and the probability of retention was 91.6% at 12 months, 87.8% at 24 months, and 78.7% at 60 months. Retention in care was more pronounced among women and more significant among PLWH aged 35 years and older when treatment was initiated in health care facilities offering the full range of activities (care and treatment, active patient search, presence of social mediators).ConclusionOur study, conducted during the Covid-19 pandemic, shows acceptable retention rates in care for PLWH. These results make possible to propose solutions to improve the care program in the country: the harmonization of procedures for tracing PLWH with the implementation of their active search (with the help of community mediators) and the dispensing of ART to PLWH for three or six months.

27 Jun 2024·Global Health: Science and Practice

Acceptability of an Incentivized Peer Referral Intervention to Address COVID-19 Vaccine Hesitancy Among Adults in Yopougon-Est, Côte d’Ivoire

Article

Author: Burke, Holly M ; Ouattara, Mariame Louise ; Pedersen, Brian ; Ranebennur, Virupax ; Albert, Yao Kouakou ; Thanel, Katherine ; Gbeke, Dorgeles

INTRODUCTIONVaccine hesitancy persists as a barrier to vaccine uptake among adults across geographies. We pilot-tested an incentivized peer referral intervention in Yopougon-Est, Côte d'Ivoire, to encourage adults who recently received COVID-19 vaccination to discuss their experiences and motivate family and friends to seek vaccination.Implementation: From May through June 2023, the intervention operated at 2 vaccination sites, where staff approached individuals immediately after receiving COVID-19 vaccination. Interested vaccine recipients received up to 9 referral coupons to distribute among their social circles, with a small financial incentive (approximately US$3) offered for each person they referred who returned to 1 of the 2 sites for COVID-19 vaccination.METHODSWe collected data on numbers of people vaccinated and coupons returned. Qualitative interviews were conducted with 40 referred vaccine recipients and 7 public health officials.RESULTSDuring the 6-week intervention, 450 newly vaccinated individuals were offered the opportunity to enroll, with 197 opting to distribute coupons. Nearly half (45%) of these peer mobilizers who distributed coupons referred at least 1 person who subsequently came in for vaccination, and most of this subset had 2 or more completed referrals. Qualitative findings revealed that coupons served as effective reminders, sparking discussions within social networks and prompting vaccine-seeking behavior. According to the referred vaccine recipients, hearing about their peers' vaccination experience influenced uptake. Vaccine recipients and public health officials found the small referral incentive acceptable. Officials noted the intervention's potential utility and cost effectiveness, suggesting possible sustainability.CONCLUSIONThis incentivized peer referral intervention, capitalizing on peer networks and social norms, holds promise for increasing vaccine uptake in Yopougon-Est and potentially in other vaccination contexts globally. Practitioners can leverage the implementation guide and training materials we developed to replicate the intervention at larger scale and assess impact on vaccination trends.

News (Medical) associated with FHI 360

19 Oct 2005

·www.biospace.com

Multi-Country Phase III Clinical Trials To Test Microbicides To Prevent HIV Infection

The CONRAD program of the Eastern Virginia Medical School today announced that it has received a $12M grant from the Bill & Melinda Gates Foundation, with $12 million in matching funds committed by the US Agency for International Development (USAID), for a total of $24M. This grant plus the USAID award will allow two multi-country Phase III clinical trials of a product to prevent the transmission of HIV/AIDS. The main goal of the project is to determine if a vaginal microbicide candidate is an effective and safe method for preventing HIV transmission. CONRAD plans to meet this goal by completing two Phase III HIV prevention trials with a gel consisting of 6% cellulose sulfate (CS), also known as Ushercell®, developed by CONRAD in collaboration with Polydex Pharmaceuticals Limited, a publicly quoted (POLXF, Nasdaq) Canadian company. One trial, implemented by CONRAD, will be conducted in India and four African countries. This trials will be funded equally by the Gates Foundation and USAID. The other trial, initiated in late 2004 in Nigeria in collaboration with Family Health International (FHI), is entirely supported by USAID.

Phase 3

100 Deals associated with FHI 360

100 Translational Medicine associated with FHI 360

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