Effective Aids Treatment and Support in the Free State (FEATS)

NCT00821366 | Unknown Phase 3

• 1 other identifier: FEATS
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 12

Brief Summary

The aim of this study is to investigate the benefits of ARV treatment to patients, to the family members of patients on ARV treatment, and to communities at large. The study also aims to investigate the impact of a peer adherence support and a nutritional intervention on measures of treatment success. To this end, 648 patients who had commenced ARV treatment in the past month at twelve selected health care facilities will be recruited into the study. In addition, 204 randomly sampled households from the communities served by the twelve selected clinics will be recruited into the study. Trained enumerators will at baseline conduct semi-structured interviews with patients and households. Following the baseline survey, patients recruited into the study will be randomly assigned to one of three groups:

• Patients receiving ARV treatment and the associated support currently provided in the public sector ARV treatment programme.
• Patients receiving (a) plus bi-weekly visits by an experienced ARV patient who has been trained as a peer adherence supporter
• Patients receiving (a) and (b) plus a weekly nutritional supplement in the form of two 400g cans of meatballs and spaghetti in tomato sauce The group of 'comparison' households comprises the fourth group. Trained enumerators will conduct follow-up interviews with all patients and households at approximately six- and at twelve-months respectively. In addition, the ARV coordinator and other providers working in the ARV treatment programme at each of the twelve selected health care facilities will be interviewed by trained enumerators, at baseline and again at six- and at twelve-months. Clinical data will be obtained from patient files at baseline and at completion of the study. Using these data, various outcomes of importance to the study will be compared between the four study groups, using experimental and non-experimental methods.

Conditions

HIV/AIDS; Food Insecurity; HIV Infections

Keywords

HIV/AIDS; Food security; treatment experienced

Outcome Measures

Primary Outcomes (9)

• CD4 count

  6-monthly

• RNA viral load

  6-monthly

• Haemoglobin

  6-monthly

• self-reported adherence (CASE index)

  6-monthly

• health-related quality of life (EQ-5D/EQ-VAS)

  6-monthly

• anthropometrics

  monthly to 6-monthly

• food security (USDA scales)

  6-monthly

• time allocation/physical activity levels

  6-monthly

• household welfare

  6-monthly

Secondary Outcomes (5)

• mental health (HADS/MHI scales)

  6-monthly

• labour force participation

  6-monthly

• employment status

  6-monthly

• self-reported sexual behaviour

  6-monthly

• school attendance/performance

  6-monthly

Study Arms (4)

1

ACTIVE COMPARATOR

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment only group

Drug: ARV treatment

2

ACTIVE COMPARATOR

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment and ARV peer adherence support group

Behavioral: ARV peer adherence support (PAS); Drug: ARV treatment

3

ACTIVE COMPARATOR

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme - ARV treatment, ARV peer adherence support and nutritional support group

Behavioral: ARV peer adherence support (PAS); Dietary Supplement: Nutritional support; Drug: ARV treatment

4

NO INTERVENTION

Randomly selected households from the general community served by the selected health facility, excluding households where someone is known to receive ARV treatment - comparison/control group

Interventions

ARV peer adherence support (PAS) BEHAVIORAL

Adherence support provided during twice weekly visits to the patient by an experienced ART patients who received basic training in ARV peer adherence support

2; 3

Nutritional support DIETARY_SUPPLEMENT

Weekly delivery by peer adherence supporter (PAS) of two 400g cans of meatballs and spaghetti in tomato sauce

3

ARV treatment DRUG

Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-positive
• Eligible for public sector ARV treatment (CD4\<200 and/or WHO stage 4)
• Commenced ARV treatment in past 4 weeks
• Patient resident in town/village where ART clinic located

You may not qualify if:

• HIV-negative
• Not eligible for public sector ARV treatment
• Had not commenced ARV treatment
• Commenced ARV treatment longer than one month ago
• Patient not resident in town/village where ART clinic

Sponsors & Collaborators

• Centre for Health Systems Research & Development, University of the Free State: lead
• World Bank: collaborator
• Bank-Netherlands Partnership Programme (BNPP): collaborator

Study Sites (12)

Batho clinic

Bloemfontein, Free State, South Africa

Location

MUCPP clinic

Bloemfontein, Free State, South Africa

Location

Tswelepele clinic

Bloemfontein, Free State, South Africa

Location

Refengkhotso clinic

Deneysville, Free State, South Africa

Location

Tshiame clinic

Harrismith, Free State, South Africa

Location

Itumeleng clinic

Jagersfontein, Free State, South Africa

Location

Phomolong clinic

Phomolong, Free State, South Africa

Location

Namahali clinic

Phuthaditjaba, Free State, South Africa

Location

Tseki clinic

Phuthaditjaba, Free State, South Africa

Location

Zamdela clinic

Sasolburg, Free State, South Africa

Location

Matjhabeng clinic

Welkom, Free State, South Africa

Location

Welkom clinic

Welkom, Free State, South Africa

Location

Related Publications (1)

• Bhargava A, Booysen FLR, Walsh CM. Health status, food insecurity, and time allocation patterns of patients with AIDS receiving antiretroviral treatment in South Africa. AIDS Care. 2018 Mar;30(3):361-368. doi: 10.1080/09540121.2017.1371665. Epub 2017 Sep 1.

  PMID: 28862017 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Nutritional Support

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Frikkie LR Booysen, PhD

  University of the Free State

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: January 13, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: February 26, 2009

Record last verified: 2009-01

Locations

ZA (12)