Effective Aids Treatment and Support in the Free State (FEATS) (FEATS)
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ClinicalTrials.gov Identifier: NCT00821366 |
Recruitment Status : Unknown
Verified January 2009 by Centre for Health Systems Research & Development, University of the Free State.
Recruitment status was: Active, not recruiting
First Posted : January 13, 2009
Last Update Posted : February 26, 2009
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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.
Condition or disease | Intervention/treatment | Phase |
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HIV/AIDS Food Insecurity HIV Infections | Behavioral: ARV peer adherence support (PAS) Dietary Supplement: Nutritional support Drug: ARV treatment | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 648 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effective Aids Treatment and Support in the Free State (FEATS): Adherence and Nutritional Support for Effective and Sustainable Antiretroviral Treatment in Resource Constrained Settings |
Study Start Date : | October 2007 |
Estimated Primary Completion Date : | December 2009 |
Estimated Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
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Active Comparator: 1
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
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Drug: ARV treatment
Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme |
Active Comparator: 2
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
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Behavioral: ARV peer adherence support (PAS)
Adherence support provided during twice weekly visits to the patient by an experienced ART patients who received basic training in ARV peer adherence support Drug: ARV treatment Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme |
Active Comparator: 3
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
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Behavioral: ARV peer adherence support (PAS)
Adherence support provided during twice weekly visits to the patient by an experienced ART patients who received basic training in ARV peer adherence support Dietary Supplement: Nutritional support Weekly delivery by peer adherence supporter (PAS) of two 400g cans of meatballs and spaghetti in tomato sauce Drug: ARV treatment Households including ARV patients who receive the ARV treatment and associated support provided as part of government's ARV treatment programme |
No Intervention: 4
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
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- CD4 count [ Time Frame: 6-monthly ]
- RNA viral load [ Time Frame: 6-monthly ]
- Haemoglobin [ Time Frame: 6-monthly ]
- self-reported adherence (CASE index) [ Time Frame: 6-monthly ]
- health-related quality of life (EQ-5D/EQ-VAS) [ Time Frame: 6-monthly ]
- anthropometrics [ Time Frame: monthly to 6-monthly ]
- food security (USDA scales) [ Time Frame: 6-monthly ]
- time allocation/physical activity levels [ Time Frame: 6-monthly ]
- household welfare [ Time Frame: 6-monthly ]
- mental health (HADS/MHI scales) [ Time Frame: 6-monthly ]
- labour force participation [ Time Frame: 6-monthly ]
- employment status [ Time Frame: 6-monthly ]
- self-reported sexual behaviour [ Time Frame: 6-monthly ]
- school attendance/performance [ Time Frame: 6-monthly ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821366
South Africa | |
Batho clinic | |
Bloemfontein, Free State, South Africa | |
MUCPP clinic | |
Bloemfontein, Free State, South Africa | |
Tswelepele clinic | |
Bloemfontein, Free State, South Africa | |
Refengkhotso clinic | |
Deneysville, Free State, South Africa | |
Tshiame clinic | |
Harrismith, Free State, South Africa | |
Itumeleng clinic | |
Jagersfontein, Free State, South Africa | |
Phomolong clinic | |
Phomolong, Free State, South Africa | |
Namahali clinic | |
Phuthaditjaba, Free State, South Africa | |
Tseki clinic | |
Phuthaditjaba, Free State, South Africa | |
Zamdela clinic | |
Sasolburg, Free State, South Africa | |
Matjhabeng clinic | |
Welkom, Free State, South Africa | |
Welkom clinic | |
Welkom, Free State, South Africa |
Study Director: | Frikkie LR Booysen, PhD | University of the Free State |
Responsible Party: | Professor Frikkie Booysen, University of the Free State |
ClinicalTrials.gov Identifier: | NCT00821366 |
Other Study ID Numbers: |
FEATS |
First Posted: | January 13, 2009 Key Record Dates |
Last Update Posted: | February 26, 2009 |
Last Verified: | January 2009 |
HIV/AIDS Food security treatment experienced |
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |