Dataset Information

Supporting Treatment for Anti-Retroviral Therapy (START) Together: Protocol for a pilot, randomized, couple-based intervention to promote women's ART adherence and men's engagement in HIV care in KwaZulu-Natal, South Africa.

ABSTRACT:

Background

South Africa currently has the greatest number of people with HIV globally. The country has not yet met its 95-95-95 goals, with different gaps in the HIV care cascade for women and men. This paper reports on a protocol to pilot test a couple-based intervention designed to improve women's antiretroviral therapy (ART) adherence and men's engagement in care in heterosexual couples living in the Vulindlela area of KwaZulu-Natal, South Africa. Study goals are two-fold: (1) assess the acceptability, feasibility, and fidelity of the experimental intervention, START Together, and (2) collect efficacy data on START Together for women's ART adherence, men's engagement in HIV care, and the couple's relationship functioning.

Methods

Women (N = 20) who were not engaged with ART adherence (defined via self-reported ART difficulties, record of missed clinic visits, or viral non-suppression) are the target patients; male partners are not required to know or disclose their HIV status to be part of the study. Couples are randomized 1:1 to the experimental treatment (START Together) or treatment as usual (referrals to the local clinic to support ART adherence or any other HIV-related care). START Together is a 5-session intervention based in cognitive-behavioral couple therapy, which is a skill-based intervention focusing on communication and problem-solving skills, and Life Steps, a problem-solving intervention identifying barriers and solutions to medication adherence. Couples are assessed at baseline, post-treatment (8 weeks post-randomization), and follow-up (12 weeks post-randomization).

Conclusion

This study will provide preliminary implementation and efficacy data on whether this novel approach has potential to improve women and men's HIV and healthcare-related needs.

SUBMITTER: Belus JM

PROVIDER: S-EPMC9464877 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Supporting Treatment for Anti-Retroviral Therapy (START) Together: Protocol for a pilot, randomized, couple-based intervention to promote women's ART adherence and men's engagement in HIV care in KwaZulu-Natal, South Africa.

Belus Jennifer M JM van Heerden Alastair A van Rooyen Heidi H Bradley Valerie D VD Magidson Jessica F JF Hines Abigail C AC Barnabas Ruanne V RV

Contemporary clinical trials communications 20220818

<h4>Background</h4>South Africa currently has the greatest number of people with HIV globally. The country has not yet met its 95-95-95 goals, with different gaps in the HIV care cascade for women and men. This paper reports on a protocol to pilot test a couple-based intervention designed to improve women's antiretroviral therapy (ART) adherence and men's engagement in care in heterosexual couples living in the Vulindlela area of KwaZulu-Natal, South Africa. Study goals are two-fold: (1) assess ...[more]

PMID: 36105267

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Project description:BackgroundSince mental health may influence HIV care among people living with HIV (PLHIV), we sought to evaluate the impact of anxiety and depression on ART initiation and HIV-related outcomes.MethodsWe conducted a prospective cohort study of PLHIV in the Umlazi Township of KwaZulu-Natal, South Africa. We measured depression using the Patient Health Questionnaire (PHQ-9) and anxiety using the Generalized Anxiety Disorder (GAD-7) scale, both of which have been validated in sub-Saharan Africa, among all patients prior to receiving a positive HIV test. We then followed those who tested HIV+ for 12 months to determine their time to ART initiation, missing clinic visits or refills, retention in care, hospitalization, and death. We used logistic regression models, adjusted for socio-demographic characteristics such as age and sex, to examine the effects of baseline measures of depression and anxiety on ART initiation and HIV treatment outcomes.FindingsAmong 2,319 adult PLHIV, mean age was 33 years (SD=9.3 years), 57% were female, and baseline median CD4 count was 317 cells/mm3 (IQR=175-491 cells/mm3). In univariate analyses, depression was associated with slower rates of ART initiation. In adjusted models, PLHIV with depression had lower odds of initiating ART within 90 days of HIV testing (aOR=0.60, 95% CI=0.46, 0.79, p<0.01), and lower odds of being retained in care (aOR=0.77, 95% CI=0.60, 0.99, p = 0.04). By the end of the 12-month study period, odds of ART initiation among PLHIV with depression were higher than the first 90 days but still significantly lower compared to those without depression (aOR=0.72, 95% CI=0.52, 0.99, p = 0.04). Among PLHIV who initiated ART, depression was associated with a lower odds of missing clinic visits (aOR=0.54, 95% CI= 0.40, 0.73, p<0.01). Anxiety was strongly correlated with depression (r = 0.77, p<0.01) and had similar effects on HIV-related outcomes.InterpretationsThe presence of depression is a significant barrier to ART initiation and retention in care among adult PLHIV in South Africa. Mental health screenings around the time of HIV testing may help improve linkage and HIV-related outcomes.FundingThis work was supported by the Infectious Disease Society of America Education & Research Foundation and National Foundation for Infectious Diseases (PKD); Massachusetts General Hospital Executive Committee on Research (PKD); the Harvard University Center for AIDS Research [AI060354] (PKD); and the National Institute of Allergy and Infectious Diseases [AI108293, AI143351] (PKD). The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health or other funding agencies.

Project description:ObjectivesResearch on migration and HIV has largely focused on male migration, often failing to measure HIV risks associated with migration for women. We aimed to establish whether associations between migration and HIV infection differ for women and men, and identify possible mechanisms by which women's migration contributes to their high infection risk.DesignData on socio-demographic characteristics, patterns of migration, sexual behavior and HIV infection status were obtained for a population of 11,677 women aged 15-49 and men aged 15-54, resident members of households within a demographic surveillance area participating in HIV surveillance in 2003-04.MethodsLogistic regression was conducted to examine whether sex and migration were independently associated with HIV infection in three additive effects models, using measures of recent migration, household presence and migration frequency. Multiplicative effects models were fitted to explore whether the risk of HIV associated with migration differed for males and females. Further modeling and simulations explored whether composition or behavioral differences accounted for observed associations.ResultsRelative to non-migrant males, non-migrant females had higher odds of being HIV-positive (adjusted odds ratio [aOR] = 1.72; 95% confidence interval [1.49-1.99]), but odds were higher for female migrants (aOR = 2.55 [2.07-3.13]). Female migrants also had higher odds of infection relative to female non-migrants (aOR = 1.48 [1.23-1.77]). The association between number of sexual partners over the lifetime and HIV infection was modified by both sex and migrant status: For male non-migrants, each additional partner was associated with 3% higher odds of HIV infection (aOR = 1.03 [1.02-1.05]); for male migrants the association between number of partners and HIV infection was non-significant. Each additional partner increased odds of HIV infection by 22% for female non-migrants (aOR = 1.22 [1.12-1.32]) and 46% for female migrants (aOR = 1.46 [1.25-1.69]).ConclusionsHigher risk sexual behavior in the context of migration increased women's likelihood of HIV infection.

Dataset Information

Supporting Treatment for Anti-Retroviral Therapy (START) Together: Protocol for a pilot, randomized, couple-based intervention to promote women's ART adherence and men's engagement in HIV care in KwaZulu-Natal, South Africa.

Background

Methods

Conclusion

Publications

Supporting Treatment for Anti-Retroviral Therapy (START) Together: Protocol for a pilot, randomized, couple-based intervention to promote women's ART adherence and men's engagement in HIV care in KwaZulu-Natal, South Africa.

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