Non-Communicable Diseases and Antiretroviral Therapy Outcomes in the RapIT Study Population

NCT02012972 | Completed

• 3 other identifiers: H-32549U01AI100015M130958
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

For national antiretroviral therapy (ART) programs, the most important health system goals in reducing morbidity and mortality among HIV-infection patients are to initiate treatment as early as eligibility criteria allow and to achieve the highest possible long-term retention of patients on ART. In South Africa, cohort data have consistently found high attrition among ART patients, with the combined cumulative outcomes of death and loss to follow up averaging 25-40% over the first five years after ART initiation. Like many other middle income countries, South Africa also faces very high rates of non-communicable diseases (NCDs) and NCD risks. Despite this, there are virtually no studies looking at interactions between ART and NCDs, and none that have considered the effect of NCDs and NCD risk factors on achieving the second health system goal mentioned above: long term retention on ART.

Conditions

Antiretroviral Therapy, Highly Active; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Keywords

Antiretroviral therapy; HIV/AIDS; Non-communicable diseases; South Africa

Outcome Measures

Primary Outcomes (1)

• NCDs and NCD risk factors in the study population by time on ART

  The outcomes for primary objective 1 will be NCDs and NCD risk factors in the study population by time on ART, including diabetes, cardiovascular disease, respiratory conditions, hypertension, obesity, and behavioral risks such as smoking and alcohol use.

  Baseline

Secondary Outcomes (3)

• HIV treatment outcomes

  Baseline

• Uptake of NCD care

  6 months

• Changes in NCD risks or prevalence

  6 months

Study Arms (2)

NCD Risks

Study subjects with NCD risks or disease at enrollment. Each of these subjects will have a Referral for NCD care

Behavioral: Referral for NCD care

No NCD Risks

Study subjects without NCD risks or disease at enrollment.

Interventions

Referral for NCD care BEHAVIORAL

Subjects in the NCD Risks group not already receiving care for the condition will be referred to a primary health clinic for care.

NCD Risks

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be non-pregnant adults who initiated antiretroviral therapy (ART) for HIV at least 12 months prior to study enrollment and are at least 35 years old. The age restriction will allow the study to focus on older patients who are at greater risk of NCDs. Pregnant women will be excluded because they face a different set of NCD risks directly related to pregnancy; women less than 6 months post-partum are also excluded to allow for the remaining effects of pregnancy.

You may qualify if:

• Adult ART patients \>35 years old.
• Initiated ART at least 12 months prior to study enrollment.
• Presenting at study clinic for a routine ART monitoring visit.

You may not qualify if:

• Pregnant or within first six months post-partum.
• Already enrolled in the RapIT study or another research study.
• Stated intention to transfer care to another location during the next 12 months.
• Not physically or emotionally able to participate in the study, in the opinion of the investigators.
• Not willing or able to provide written informed consent to participate in the study.
• Previously enrolled in the same study.

Sponsors & Collaborators

• Boston University: lead
• University of Witwatersrand, South Africa: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• City of Johannesburg: collaborator

Study Sites (1)

Thuthukani Health Centre

Johannesburg, Gauteng, South Africa

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Acquired Immunodeficiency Syndrome; Noncommunicable Diseases

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Sydney Rosen, MPA

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 17, 2013
• Study Start: January 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)