Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial

被引：13

作者：

Hoffman, Risa ^{[1
,2
]}

Bardon, Ashley ^{[1
,2
]}

Rosen, Sydney ^{[2
,3
,4
]}

Fox, Matthew ^{[2
,5
]}

Kalua, Thoko ^{[6
]}

Xulu, Thembi ^{[2
,7
]}

Taylor, Angela ^{[7
,8
]}

Sanne, Ian ^{[2
,7
,9
]}

机构：

[1] UCLA, Dept Med, Div Infect Dis, 10833 Conte Ave,37-121 CHS, Los Angeles, CA 90095 USA

[2] EQUIP, 3rd Floor Outspan Bldg,1006 Lenchen North Ave, Centurion, South Africa

[3] Boston Univ, Sch Publ Hlth, Crosstown Ctr, Dept Global Hlth, 801 Massachusetts Ave, Boston, MA 02118 USA

[4] Univ Witwatersrand, Fac Hlth Sci, Sch Clin Med, Health Econ & Epidemiol Res Off,Dept Internal Med, Johannesburg, South Africa

[5] Boston Univ, Sch Publ Hlth, Crosstown Ctr, Dept Epidemiol, 801 Massachusetts Ave, Boston, MA 02118 USA

[6] Malawi Minist Hlth, POB 30377, Capital City, Lilongwe, Malawi

[7] Right Care, 3rd Floor Outspan Bldg,1006 Lenchen North Ave, Centurion, South Africa

[8] EQUIP Zambia, 11059 Brentwood Rd,Mikwala House, Lusaka, Zambia

[9] Univ Witwatersrand, Fac Hlth Sci, Dept Med, 1 York Ave, ZA-2193 Parktown, South Africa

来源：

TRIALS | 2017年 / 18卷

关键词：

Antiretroviral therapy; HIV; Africa; ART dispensing; Retention; Virologic suppression; Cost-effectiveness; STABLE PATIENTS; SOUTH-AFRICA; THERAPY;

D O I：

10.1186/s13063-017-2177-z

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: Requirements for frequent dispensing of antiretroviral therapy (ART) place demands on health systems and can lead to suboptimal adherence and disengagement in care for patients due to the time and cost of frequent clinic visits. Rigorous data are needed to define optimal ART dispensing strategies and to evaluate the impact of a longer medication supply on retention and virologic suppression and determine whether this strategy lowers costs for both the patient and the health system. To date, no randomized studies have tested the benefits of 6-month dispensing of ART compared to 3-month and standard of care approaches. Methods: This study will be an unblinded cluster-randomized, matched controlled trial conducted among 8200 stable, HIV-infected individuals age 18 years and older on ART in Malawi and Zambia, to compare three ART dispensing intervals on the outcomes of retention in care (primary outcome), virologic suppression, and cost-effectiveness. Thirty clusters will be matched according to country, facility type, and ART cohort size and randomized to one of three study arms: standard of care, 3-month dispensing, and 6-month dispensing. Study participants will be followed, and outcomes will be measured at 12, 24, and 36 months. A subset of participants (n = 240) and providers (n = 180) will also participate in qualitative interviews to evaluate feasibility and acceptability of different ART dispensing intervals. Discussion: This study will be the first to compare 6-month and 3-month ART dispensing intervals for stable, HIV-infected individuals in Malawi and Zambia. We focus on outcomes relevant to country programs, including retention, virologic suppression, and cost-effectiveness. Results from the study will help resource-limited health systems better understand the full scope of outcomes resulting from various ART dispensing intervals and help to inform health policy decisions.

引用

页数：10

共 17 条

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