Cargando…

A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, “Strengthening Our Vows”: Study protocol and baseline data

BACKGROUND: Heterosexual couples contribute to most new HIV infections in areas of generalized HIV epidemics in sub-Saharan Africa. After Couples’ Voluntary HIV Counseling and Testing (CVCT), heterosexual concordant HIV negative couples (CNC) in cohabiting unions contribute to approximately 47% of r...

Descripción completa

Detalles Bibliográficos
Autores principales: Sharkey, Tyronza, Wall, Kristin M., Parker, Rachel, Tichacek, Amanda, Pappas-DeLuca, Katina A., Kilembe, William, Inambao, Mubiana, Malama, Kalonde, Hoagland, Alexandra, Peeling, Rosanna, Allen, Susan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8481973/
https://www.ncbi.nlm.nih.gov/pubmed/34622087
http://dx.doi.org/10.1016/j.conctc.2021.100850
_version_ 1784576801946730496
author Sharkey, Tyronza
Wall, Kristin M.
Parker, Rachel
Tichacek, Amanda
Pappas-DeLuca, Katina A.
Kilembe, William
Inambao, Mubiana
Malama, Kalonde
Hoagland, Alexandra
Peeling, Rosanna
Allen, Susan
author_facet Sharkey, Tyronza
Wall, Kristin M.
Parker, Rachel
Tichacek, Amanda
Pappas-DeLuca, Katina A.
Kilembe, William
Inambao, Mubiana
Malama, Kalonde
Hoagland, Alexandra
Peeling, Rosanna
Allen, Susan
author_sort Sharkey, Tyronza
collection PubMed
description BACKGROUND: Heterosexual couples contribute to most new HIV infections in areas of generalized HIV epidemics in sub-Saharan Africa. After Couples’ Voluntary HIV Counseling and Testing (CVCT), heterosexual concordant HIV negative couples (CNC) in cohabiting unions contribute to approximately 47% of residual new infections in couples. These infections are attributed to concurrent sexual partners, a key driver of the HIV epidemic in Zambia. METHODS/DESIGN: Ten Zambian government clinics in two of the largest cities were randomized in matched pairs to a Strengthening Our Vows (SOV) intervention or a Good Health Package (GHP) comparison arm. SOV addressed preventing HIV infection from concurrent partners and protecting spouses after exposures outside the relationship. GHP focused on handwashing; water chlorination; household deworming; and screening for hypertension, diabetes and schistosomiasis. CNC were referred from CVCT services in government clinics. Follow-up includes post-intervention questionnaires and outcome assessments through 60 months. Longitudinal outcomes of interest include self-report and laboratory markers of condomless sex with outside partners and reported sexual agreements. We present baseline characteristics and factors associated with study arm and reported risk using descriptive statistics. RESULTS: The mean age of men was 32 and 26 for women. On average, couples cohabited for 6 years and had 2 children. Baseline analyses demonstrated some failures of randomization by study arm which will be considered in future primary analyses of longitudinal data. An HIV/STI risk factor composite was not different in the two study arms. Almost one-quarter of couples had an HIV risk factor at baseline. DISCUSSION: In preparation for future biomedical and behavioral interventions in sub-Saharan Africa, it is critical to understand and decrease HIV risk within CNC.
format Online
Article
Text
id pubmed-8481973
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Elsevier
record_format MEDLINE/PubMed
spelling pubmed-84819732021-10-06 A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, “Strengthening Our Vows”: Study protocol and baseline data Sharkey, Tyronza Wall, Kristin M. Parker, Rachel Tichacek, Amanda Pappas-DeLuca, Katina A. Kilembe, William Inambao, Mubiana Malama, Kalonde Hoagland, Alexandra Peeling, Rosanna Allen, Susan Contemp Clin Trials Commun Article BACKGROUND: Heterosexual couples contribute to most new HIV infections in areas of generalized HIV epidemics in sub-Saharan Africa. After Couples’ Voluntary HIV Counseling and Testing (CVCT), heterosexual concordant HIV negative couples (CNC) in cohabiting unions contribute to approximately 47% of residual new infections in couples. These infections are attributed to concurrent sexual partners, a key driver of the HIV epidemic in Zambia. METHODS/DESIGN: Ten Zambian government clinics in two of the largest cities were randomized in matched pairs to a Strengthening Our Vows (SOV) intervention or a Good Health Package (GHP) comparison arm. SOV addressed preventing HIV infection from concurrent partners and protecting spouses after exposures outside the relationship. GHP focused on handwashing; water chlorination; household deworming; and screening for hypertension, diabetes and schistosomiasis. CNC were referred from CVCT services in government clinics. Follow-up includes post-intervention questionnaires and outcome assessments through 60 months. Longitudinal outcomes of interest include self-report and laboratory markers of condomless sex with outside partners and reported sexual agreements. We present baseline characteristics and factors associated with study arm and reported risk using descriptive statistics. RESULTS: The mean age of men was 32 and 26 for women. On average, couples cohabited for 6 years and had 2 children. Baseline analyses demonstrated some failures of randomization by study arm which will be considered in future primary analyses of longitudinal data. An HIV/STI risk factor composite was not different in the two study arms. Almost one-quarter of couples had an HIV risk factor at baseline. DISCUSSION: In preparation for future biomedical and behavioral interventions in sub-Saharan Africa, it is critical to understand and decrease HIV risk within CNC. Elsevier 2021-09-23 /pmc/articles/PMC8481973/ /pubmed/34622087 http://dx.doi.org/10.1016/j.conctc.2021.100850 Text en © 2021 Published by Elsevier Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Sharkey, Tyronza
Wall, Kristin M.
Parker, Rachel
Tichacek, Amanda
Pappas-DeLuca, Katina A.
Kilembe, William
Inambao, Mubiana
Malama, Kalonde
Hoagland, Alexandra
Peeling, Rosanna
Allen, Susan
A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, “Strengthening Our Vows”: Study protocol and baseline data
title A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, “Strengthening Our Vows”: Study protocol and baseline data
title_full A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, “Strengthening Our Vows”: Study protocol and baseline data
title_fullStr A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, “Strengthening Our Vows”: Study protocol and baseline data
title_full_unstemmed A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, “Strengthening Our Vows”: Study protocol and baseline data
title_short A cluster randomized trial to reduce HIV risk from outside partnerships in Zambian HIV-Negative couples using a novel behavioral intervention, “Strengthening Our Vows”: Study protocol and baseline data
title_sort cluster randomized trial to reduce hiv risk from outside partnerships in zambian hiv-negative couples using a novel behavioral intervention, “strengthening our vows”: study protocol and baseline data
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8481973/
https://www.ncbi.nlm.nih.gov/pubmed/34622087
http://dx.doi.org/10.1016/j.conctc.2021.100850
work_keys_str_mv AT sharkeytyronza aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT wallkristinm aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT parkerrachel aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT tichacekamanda aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT pappasdelucakatinaa aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT kilembewilliam aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT inambaomubiana aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT malamakalonde aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT hoaglandalexandra aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT peelingrosanna aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT allensusan aclusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT sharkeytyronza clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT wallkristinm clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT parkerrachel clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT tichacekamanda clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT pappasdelucakatinaa clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT kilembewilliam clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT inambaomubiana clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT malamakalonde clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT hoaglandalexandra clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT peelingrosanna clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata
AT allensusan clusterrandomizedtrialtoreducehivriskfromoutsidepartnershipsinzambianhivnegativecouplesusinganovelbehavioralinterventionstrengtheningourvowsstudyprotocolandbaselinedata