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出境医 / 临床实验 / Pilot Test of a Couple-Based Medication Adherence Intervention for HIV-Positive Women and Their Male Partners in South Africa

Pilot Test of a Couple-Based Medication Adherence Intervention for HIV-Positive Women and Their Male Partners in South Africa

Study Description
Brief Summary:
The purpose of this study is to collect quantitative data related to developing and testing a couple-based intervention (CBI) for HIV-positive women's medication adherence in the region of Kwazulu-Natal, South Africa. The CBI, called START (Supporting Treatment for Anti-Retroviral Therapy) Together, will be a manualized intervention focused on women's ART adherence and enhancing the couple's communication and problem-solving behavior. The preliminary efficacy of the CBI on HIV-positive women's ART adherence, men's HIV testing, and HIV-positive men's linkage to care will be compared to a control condition of referrals to usual HIV care.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Behavioral: START Together Not Applicable

Detailed Description:
South Africa (SA) has one of the highest global HIV burdens with clear gender disparities. For men, 57% of HIV-related deaths occur among persons who have never sought HIV care. Women, in comparison, have high rates of HIV testing and are linked to care through antenatal services, but only 45% are virally suppressed on antiretroviral therapy (ART). Thus, tailored interventions for HIV are needed. In order to end the AIDS epidemic, the ambitious "90-90-90" goal was developed by UNAIDS to test, treat, and maintain medication adherence for 73% of HIV-positive individuals. Separate gender-specific interventions have been developed along the HIV care cascade to treat the different needs of men and women. However, no study to date has used one intervention to concurrently meet the unique HIV-related needs for women and men. Couple-based interventions (CBIs) can achieve this goal. CBIs are more efficacious than interventions delivered to individuals in enhancing a number of HIV protective behaviors. HIV is also primarily transmitted in the context of stable heterosexual relationships in sub-Saharan Africa; about 50% of new infections occur in serodiscordant relationships, making the use of a CBI especially relevant. The purpose of this study is to strengthen the HIV care cascade in SA by developing a CBI that concurrently addresses the needs of women and men to meet the "90-90-90" goal. This study will be conducted in the province of KwaZulu-Natal, SA. HIV-positive women who are in a heterosexual relationship and non-adherent to ART will be recruited to participate in the study with their male partners. Twenty couples will be recruited and randomized to either receive the START Together program or to the control condition and followed for 10 weeks thereafter.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supporting Treatment for Anti-Retroviral Therapy (START) Together: Development of a Couple-based Medication Adherence Intervention for HIV-positive Women and Their Male Partners in Sweetwaters, South Africa
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: START Together
Couples randomized to START Together will receive the manualized treatment to enhance women's medication adherence. The treatment is anticipated to be 4 sessions in length and conducted weekly.
 Behavioral: START Together
Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.
No Intervention: Standard of Care (SOC)
Couples randomized to SOC will receive referrals to local HIV clinics to support medication adherence (for women) or other HIV-related issues (for men).
Outcome Measures
Primary Outcome Measures :
  1. HIV medication adherence for women [ Time Frame: Change from baseline assessment to approximately 10 weeks follow-up ]
    Viral load in dried blood spots


Secondary Outcome Measures :
  1. Engagement in healthcare for men [ Time Frame: Change from baseline assessment to approximately 10 weeks follow-up ]
    Dichotomous engagement in care (yes/no) will be measured by clinic records review. If clinic records are unavailable, participant self-report will be used.

  2. Relationship quality (women and men) [ Time Frame: Change from baseline assessment to approximately 6 weeks follow-up ]
    Total score on the Relationship Quality Index (RQI) from the Couple Functionality Assessment Tool (CFAT). Total scores range from 0 to 100, with higher scores indicating greater relationship quality.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 or over
  • HIV-positive women
  • Currently in a committed, heterosexual, monogamous romantic relationship with a male partner for at least 6 months
  • Both partners willing to participate in treatment to support women's ART adherence
  • Reside in Vulindlela, or neighboring community, KwaZulu-Natal, South Africa
  • Women only: must be HIV-positive and not taking ART or having difficulty maintaining ART adherence (i.e., not virally suppressed)
  • Able to comfortably communicate in either Zulu or English
  • Willing to have intervention sessions audio-recorded (if randomized to the intervention group)

Exclusion Criteria:

  • Report of moderate or severe relationship violence
  • Previously participated in a couple-based HIV prevention or treatment program
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019) 		HIV medication adherence for women [ Time Frame: Change from baseline assessment to approximately 10 weeks follow-up ]
Viral load in dried blood spots
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2019)
  • Engagement in healthcare for men [ Time Frame: Change from baseline assessment to approximately 10 weeks follow-up ]
    Dichotomous engagement in care (yes/no) will be measured by clinic records review. If clinic records are unavailable, participant self-report will be used.
  • Relationship quality (women and men) [ Time Frame: Change from baseline assessment to approximately 6 weeks follow-up ]
    Total score on the Relationship Quality Index (RQI) from the Couple Functionality Assessment Tool (CFAT). Total scores range from 0 to 100, with higher scores indicating greater relationship quality.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2019)
  • Engagement in healthcare for men [ Time Frame: Change from baseline assessment to approximately 10 weeks follow-up ]
    Dichotomous engagement in care (yes/no) will be measured by clinic records review. If clinic records are unavailable, participant self-report will be used.
  • Relationship quality (women and men) [ Time Frame: Change from baseline assessment to approximately 6 weeks follow-up ]
    Total score on the Relationship Quality Index from the Couple Functionality Assessment Tool
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Test of a Couple-Based Medication Adherence Intervention for HIV-Positive Women and Their Male Partners in South Africa
Official Title  ICMJE Supporting Treatment for Anti-Retroviral Therapy (START) Together: Development of a Couple-based Medication Adherence Intervention for HIV-positive Women and Their Male Partners in Sweetwaters, South Africa
Brief Summary The purpose of this study is to collect quantitative data related to developing and testing a couple-based intervention (CBI) for HIV-positive women's medication adherence in the region of Kwazulu-Natal, South Africa. The CBI, called START (Supporting Treatment for Anti-Retroviral Therapy) Together, will be a manualized intervention focused on women's ART adherence and enhancing the couple's communication and problem-solving behavior. The preliminary efficacy of the CBI on HIV-positive women's ART adherence, men's HIV testing, and HIV-positive men's linkage to care will be compared to a control condition of referrals to usual HIV care.
Detailed Description South Africa (SA) has one of the highest global HIV burdens with clear gender disparities. For men, 57% of HIV-related deaths occur among persons who have never sought HIV care. Women, in comparison, have high rates of HIV testing and are linked to care through antenatal services, but only 45% are virally suppressed on antiretroviral therapy (ART). Thus, tailored interventions for HIV are needed. In order to end the AIDS epidemic, the ambitious "90-90-90" goal was developed by UNAIDS to test, treat, and maintain medication adherence for 73% of HIV-positive individuals. Separate gender-specific interventions have been developed along the HIV care cascade to treat the different needs of men and women. However, no study to date has used one intervention to concurrently meet the unique HIV-related needs for women and men. Couple-based interventions (CBIs) can achieve this goal. CBIs are more efficacious than interventions delivered to individuals in enhancing a number of HIV protective behaviors. HIV is also primarily transmitted in the context of stable heterosexual relationships in sub-Saharan Africa; about 50% of new infections occur in serodiscordant relationships, making the use of a CBI especially relevant. The purpose of this study is to strengthen the HIV care cascade in SA by developing a CBI that concurrently addresses the needs of women and men to meet the "90-90-90" goal. This study will be conducted in the province of KwaZulu-Natal, SA. HIV-positive women who are in a heterosexual relationship and non-adherent to ART will be recruited to participate in the study with their male partners. Twenty couples will be recruited and randomized to either receive the START Together program or to the control condition and followed for 10 weeks thereafter.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Human Immunodeficiency Virus
Intervention  ICMJE Behavioral: START Together
Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.
Study Arms  ICMJE
  • Experimental: START Together
    Couples randomized to START Together will receive the manualized treatment to enhance women's medication adherence. The treatment is anticipated to be 4 sessions in length and conducted weekly.
    Intervention: Behavioral: START Together
  • No Intervention: Standard of Care (SOC)
    Couples randomized to SOC will receive referrals to local HIV clinics to support medication adherence (for women) or other HIV-related issues (for men).
Publications *
  • Crepaz N, Tungol-Ashmon MV, Vosburgh HW, Baack BN, Mullins MM. Are couple-based interventions more effective than interventions delivered to individuals in promoting HIV protective behaviors? A meta-analysis. AIDS Care. 2015;27(11):1361-6. doi: 10.1080/09540121.2015.1112353. Epub 2015 Nov 25.
  • Anglemyer A, Horvath T, Rutherford G. Antiretroviral therapy for prevention of HIV transmission in HIV-discordant couples. JAMA. 2013 Oct 16;310(15):1619-20. doi: 10.1001/jama.2013.278328.
  • Bor J, Rosen S, Chimbindi N, Haber N, Herbst K, Mutevedzi T, Tanser F, Pillay D, Bärnighausen T. Mass HIV Treatment and Sex Disparities in Life Expectancy: Demographic Surveillance in Rural South Africa. PLoS Med. 2015 Nov 24;12(11):e1001905; discussion e1001905. doi: 10.1371/journal.pmed.1001905. eCollection 2015 Nov.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 or over
  • HIV-positive women
  • Currently in a committed, heterosexual, monogamous romantic relationship with a male partner for at least 6 months
  • Both partners willing to participate in treatment to support women's ART adherence
  • Reside in Vulindlela, or neighboring community, KwaZulu-Natal, South Africa
  • Women only: must be HIV-positive and not taking ART or having difficulty maintaining ART adherence (i.e., not virally suppressed)
  • Able to comfortably communicate in either Zulu or English
  • Willing to have intervention sessions audio-recorded (if randomized to the intervention group)

Exclusion Criteria:

  • Report of moderate or severe relationship violence
  • Previously participated in a couple-based HIV prevention or treatment program
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809364
Other Study ID Numbers  ICMJE 395623
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jennifer Belus, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, College Park
Collaborators  ICMJE
  • Human Sciences Research Council
  • University of Washington
  • Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE Not Provided
PRS Account University of Maryland, College Park
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP