scholarly journals Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial

10.2196/15314 ◽  
2019 ◽  
Vol 8 (10) ◽  
pp. e15314
Author(s):  
Sujha Subramanian ◽  
Patrick Edwards ◽  
Sarah T Roberts ◽  
Maurice Musheke ◽  
Michael Mbizvo
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Adolescent Girls ◽  
Young Women ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Sub Saharan Africa ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Depth Interviews

Background Among countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability. Objective The goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of regular HIV testing and adherence to antiretroviral treatment. Methods We will adapt prior tools to create the SHIELD (Support for HIV Integrated Education, Linkages to Care, and Destigmatization) intervention to educate and empower Zambian AGYW of 10-24 years of age and their families and to create community-based youth clubs to foster peer support. We will also develop integrated wellness care clinics to offer a youth-friendly environment that provides tailored clinical services. We will perform formative research, including focus groups and in-depth interviews, among AGYW, caregivers, and stakeholders to help inform the development and tailoring of the interventions. A cluster-randomized controlled trial will be implemented in Lusaka, with six clinic catchment areas randomized into three groups: zones with integrated wellness care clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. We will assess HIV testing among the HIV-negative or unknown (HIV-/u) cohort, and retention in care along with viral load suppression will be evaluated in the HIV-positive (HIV+) cohort. We will use in-depth interviews and surveys to collect staff and stakeholder feedback after the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model. Results Interim results are expected in 2021, and the final results are expected in 2022. If this multilevel intervention is successful in establishing a comprehensive care continuum for HIV-affected AGYW, the Zambian Ministry of Health may advocate for expansion to additional settings to support national scale-up. Conclusions This integrated service delivery model can also be a platform to implement additional preventive services, so HIV-/u and HIV+ AGYW can receive comprehensive, integrated services. Trial Registration ClinicalTrials.gov NCT03995953; https://clinicaltrials.gov/ct2/show/NCT03995953 International Registered Report Identifier (IRRID) PRR1-10.2196/15314

scholarly journals Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Sujha Subramanian ◽  
Patrick Edwards ◽  
Sarah T Roberts ◽  
Maurice Musheke ◽  
Michael Mbizvo
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Adolescent Girls ◽  
Young Women ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Sub Saharan Africa ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Depth Interviews

BACKGROUND Among countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability. OBJECTIVE The goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of regular HIV testing and adherence to antiretroviral treatment. METHODS We will adapt prior tools to create the SHIELD (Support for HIV Integrated Education, Linkages to Care, and Destigmatization) intervention to educate and empower Zambian AGYW of 10-24 years of age and their families and to create community-based youth clubs to foster peer support. We will also develop integrated wellness care clinics to offer a youth-friendly environment that provides tailored clinical services. We will perform formative research, including focus groups and in-depth interviews, among AGYW, caregivers, and stakeholders to help inform the development and tailoring of the interventions. A cluster-randomized controlled trial will be implemented in Lusaka, with six clinic catchment areas randomized into three groups: zones with integrated wellness care clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. We will assess HIV testing among the HIV-negative or unknown (HIV-/u) cohort, and retention in care along with viral load suppression will be evaluated in the HIV-positive (HIV+) cohort. We will use in-depth interviews and surveys to collect staff and stakeholder feedback after the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model. RESULTS Interim results are expected in 2021, and the final results are expected in 2022. If this multilevel intervention is successful in establishing a comprehensive care continuum for HIV-affected AGYW, the Zambian Ministry of Health may advocate for expansion to additional settings to support national scale-up. CONCLUSIONS This integrated service delivery model can also be a platform to implement additional preventive services, so HIV-/u and HIV+ AGYW can receive comprehensive, integrated services. CLINICALTRIAL ClinicalTrials.gov NCT03995953; https://clinicaltrials.gov/ct2/show/NCT03995953

scholarly journals Digital crowdsourced intervention to promote HIV testing among MSM in China: study protocol for a cluster randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ci Ren ◽  
Joseph D. Tucker ◽  
Weiming Tang ◽  
Xiaorun Tao ◽  
Meizhen Liao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Sexual Behaviors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Testing Uptake ◽  
Self Test ◽  
Cluster Randomized

Abstract Background Men who have sex with men (MSM) are an important HIV key population in China. However, HIV testing rates among MSM remain suboptimal. Digital crowdsourced media interventions may be a useful tool to reach this marginalized population. We define digital crowdsourced media as using social media, mobile phone applications, Internet, or other digital approaches to disseminate messages developed from crowdsourcing contests. The proposed cluster randomized controlled trial (RCT) study aims to assess the effectiveness of a digital crowdsourced intervention to increase HIV testing uptake and decrease risky sexual behaviors among Chinese MSM. Methods A two-arm, cluster-randomized controlled trial will be implemented in eleven cities (ten clusters) in Shandong Province, China. Targeted study participants will be 250 MSM per arm and 50 participants per cluster. MSM who are 18 years old or above, live in the study city, have not been tested for HIV in the past 3 months, are not living with HIV or have never been tested for HIV, and are willing to provide informed consent will be enrolled. Participants will be recruited through banner advertisements on Blued, the largest gay dating app in China, and in-person at community-based organizations (CBOs). The intervention includes a series of crowdsourced intervention materials (24 images and four short videos about HIV testing and safe sexual behaviors) and HIV self-test services provided by the study team. The intervention was developed through a series of participatory crowdsourcing contests before this study. The self-test kits will be sent to the participants in the intervention group at the 2nd and 3rd follow-ups. Participants will be followed up quarterly during the 12-month period. The primary outcome will be self-reported HIV testing uptake at 12 months. Secondary outcomes will include changes in condomless sex, self-test efficacy, social network engagement, HIV testing social norms, and testing stigma. Discussion Innovative approaches to HIV testing among marginalized population are urgently needed. Through this cluster randomized controlled trial, we will evaluate the effectiveness of a digital crowdsourced intervention, improving HIV testing uptake among MSM and providing a resource in related public health fields. Trial registration ChiCTR1900024350. Registered on 6 July 2019.

scholarly journals Digital crowdsourced intervention to promote HIV testing among MSM in China: Study protocol for a cluster randomized controlled trial

2020 ◽  
Author(s):  
Ci Ren ◽  
Joseph David Tucker ◽  
Weiming Tang ◽  
Xiaorun Tao ◽  
Meizhen Liao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hiv Testing ◽  
Sexual Behaviors ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Testing Uptake ◽  
Self Test ◽  
Cluster Randomized

Abstract Background: Men who have sex with men (MSM) are an important HIV key population in China. However, HIV testing rates among MSM remain suboptimal. Digital crowdsourced media interventions may be a useful tool to reach this marginalized population. We define digital crowdsourced media as using social media, mobile phone applications, internet, or other digital approaches to disseminate messages developed from crowdsourcing contests. The proposed cluster randomized controlled trial (RCT) study aims to assess the effectiveness of a digital crowdsourced intervention to increase HIV testing uptake and decrease risky sexual behaviors among Chinese MSM.Methods: A two-arm, cluster-randomized controlled trial will be implemented in eleven cities (ten clusters) in Shandong Province, China. Targeted study participants will be 250 MSM per arm and 50 participants per cluster. MSM who are 18 years old or above, live in the study city, have not been tested for HIV in the past 3 months, are not living with HIV or have never been tested for HIV, and are willing to provide informed consent will be enrolled. Participants will be recruited through banner advertisements on Blued, the largest gay dating app in China, and in-person at community-based organizations (CBOs). The intervention includes a series of crowdsourced intervention materials (24 images and four short videos about HIV testing and safe sexual behaviors) and HIV self-test services provided by the study team. The intervention was developed through a series of participatory crowdsourcing contests before this study. The self-test kits will be sent to the participants in the intervention group at the 2nd and 3rd follow-up. Participants will be followed up quarterly during the 12-month period. The primary outcome will be self-reported HIV testing uptake at 12 months. Secondary outcomes will include changes in condomless sex, self-test efficacy, social network engagement, HIV testing social norms, and testing stigma.Discussion: Innovative approaches to HIV testing among marginalized population are urgently needed. Through this cluster randomized controlled trial, we will evaluate the effectiveness of a digital crowdsourced intervention, improving HIV testing uptake among MSM and providing a resource in related public health fields.Trial Registration: ChiCTR1900024350. Registered on 6 July 2019.

Interaction Between Insecticide Resistance-Associated Genes and Malaria Transmission in Anopheles Gambiae S. L. During a Cluster-Randomized Controlled Trial of A “lethal House Lure” in Central Côte D’ivoire

2021 ◽  
Author(s):  
Rosine Z. Wolie ◽  
Alphonsine A. Koffi ◽  
Ludovic P. Ahoua Alou ◽  
Eleanore D. Sternberg ◽  
Oulo N’Nan-Alla ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Insecticide Resistance ◽  
Anopheles Gambiae ◽  
Malaria Transmission ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Sub Saharan Africa ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background There is evidence that the Kdr L1014F and Ace-1R G119S mutations involved in pyrethroid and carbamate resistance in Anopheles gambiae influence malaria transmission in sub Saharan Africa. This is likely due to changes in behavior, life history, vectorial competence and capacity. In the present study, performed as part of a two-armed cluster randomized controlled trial (CRT) evaluating the impact of household screening plus a novel insecticide delivery system (In2Care EaveTubes), we investigated the distribution of insecticide target site mutations and their association with the infection status in wild An. gambiae s.l populations. Methods Mosquitoes were captured in 40 villages around Bouaké by human landing catches (HLC), from May 2017 to April 2019. Randomly selected sample of infected and uninfected An.gambiae s.l. with Plasmodium sp. were identified to species and then genotyped for Kdr L1014F and Ace-1R G119S mutations using quantitative polymerase chain reaction (qPCR) assays. The frequencies of the two alleles were compared between An. coluzzii and An. gambiae and then between infected and uninfected groups for each species. Results The presence of An. gambiae (49 %) and An. coluzzii (51%) was confirmed in Bouaké. Both species seemed to transmit equally Plasmodium parasites. Over the study period, the average frequency of the Kdr L1014F and Ace-1R G119S mutations did not vary significantly between study arms. However, the frequency of the Kdr L1014F and Ace-1R G119S resistance alleles were significantly higher in An. gambiae than in An. coluzzii (OR [95%CI]: 59.64 [30.81-131.63] for Kdr and OR [95%CI]: 2.79 [2.17–3.60], for Ace-1R). For both species, there were no significant differences in Kdr L1014F or Ace-1R G119S genotypic and allelic frequency distribution between infected and uninfected specimens (p > 0.05). Conclusions Either alone or in combination, Kdr L1014F and Ace-1R G119S showed no significant association with Plasmodium infection in wild An.gambiae and An. coluzzii, demonstrating similar competence for Plasmodium transmission in Bouaké. Additional factors influencing competence in natural population and those outside allele measurements contributing to resistance should be consider when establishing link between insecticide resistance and vector competence.

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