Delivering Prevention Interventions to People Living with HIV in Clinical Care Settings: Results of a Cluster Randomized Trial in Kenya, Namibia, and Tanzania

Abstract Background : Stigma and discrimination related to HIV and key populations at high risk of HIV have the potential to impede the implementation of effective HIV prevention and treatment programmes at scale. Studies measuring the impact of stigma on these programmes are rare. We are conducting an implementation science study of HIV-related stigma in communities and health settings within a large, pragmatic cluster-randomized trial of a universal testing and treatment intervention for HIV prevention in Zambia and South Africa and will assess how stigma affects, and is affected by, implementation of this intervention. Methods/Design : A mixed-method evaluation will be nested within HIV prevention trials network (HPTN) 071/PopART (Clinical Trials registration number NCT01900977), a three-arm trial comparing universal door-to-door delivery of HIV testing and referral to prevention and treatment services, accompanied by either an immediate offer of anti-retroviral treatment to people living with HIV regardless of clinical status, or an offer of treatment in-line with national guidelines, with a standard-of-care control arm. The primary outcome of HPTN 071/PopART is HIV incidence measured among a cohort of 52 500 individuals in 21 study clusters. Our evaluation will include integrated quantitative and qualitative data collection and analysis in all trial sites. We will collect quantitative data on indicators of HIV-related stigma over 3 years from large probability samples of community members, health workers and people living with HIV. We will collect qualitative data, including in-depth interviews and observations from members of these same groups sampled purposively. In analysis, we will: (1) compare HIV-related stigma measures between study arms, (2) link data on stigma to measures of the success of implementation of the PopART intervention and (3) explore changes in the dominant drivers and manifestations of stigma in study communities and the health system. Discussion : HIV-related stigma may impede the successful implementation of HIV prevention and treatment programmes. Using a novel study-design nested within a large, community randomized trial we will evaluate the extent to which HIV-related stigma affects and is affected by the implementation of a comprehensive combination HIV prevention intervention including a universal test and treatment approach.

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Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽

10.1161/hyp.70.suppl_1.p494 ◽

2017 ◽

Vol 70 (suppl_1) ◽

Author(s):

Karen L Margolis ◽

Stephen E Asche ◽

Anna R Bergdall ◽

Steven P Dehmer ◽

Beverly B Green ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Clinical Care ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Uncontrolled Hypertension ◽

Routine Clinical Care ◽

Differential Reduction ◽

Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

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AB0286 A Cluster-Randomized Trial of a Behavioral Intervention to Incorporate a Treat-To-Target Approach in the Clinical Care of Rheumatoid Arthritis Patients

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2015-eular.2424 ◽

2015 ◽

Vol 74 (Suppl 2) ◽

pp. 988.2-989 ◽

Cited By ~ 1

Author(s):

L.R. Harrold ◽

G.W. Reed ◽

J.T. Harrington ◽

C.J. Barr ◽

K.C. Saunders ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Randomized Trial ◽

Behavioral Intervention ◽

Clinical Care ◽

Cluster Randomized Trial ◽

Treat To Target ◽

Cluster Randomized

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Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol

10.21203/rs.2.12494/v1 ◽

2019 ◽

Author(s):

Margo Harrison ◽

Saskia Bunge-Montes ◽

Claudia Rivera ◽

Andrea Jimenez-Zambrano ◽

Gretchen Heinrichs ◽

...

Keyword(s):

Randomized Trial ◽

Clinical Care ◽

Cluster Randomized Trial ◽

Trial Registration ◽

Postpartum Visit ◽

Postpartum Contraception ◽

Home Setting ◽

Home Based ◽

Cluster Randomized ◽

Long Acting

Abstract Background Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. Methods This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. Discussion A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town, which is about an hour away by vehicle. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within three months of childbirth. The potential implications of this study include: nurses may be able to be trained to safely provide contraceptives, including place implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period. Retrospective Trial Registration clinicaltrials.gov Trial Identifying Number NCT04005391 Date of Registration in Primary Registry: July 1, 2019 Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04005391?term=NCT04005391&rank=1 Keywords: postpartum contraception, long-acting reversible contraceptives, implant, nursing, community programming, cluster-randomized trial

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The long-term effects of a family based economic empowerment intervention (Suubi+Adherence) on suppression of HIV viral loads among adolescents living with HIV in southern Uganda: Findings from 5-year cluster randomized trial

PLoS ONE ◽

10.1371/journal.pone.0228370 ◽

2020 ◽

Vol 15 (2) ◽

pp. e0228370 ◽

Cited By ~ 3

Author(s):

Fred M. Ssewamala ◽

Darejan Dvalishvili ◽

Claude A. Mellins ◽

Elvin H. Geng ◽

Fredderick Makumbi ◽

...

Keyword(s):

Randomized Trial ◽

Cluster Randomized Trial ◽

Economic Empowerment ◽

Long Term Effects ◽

Viral Loads ◽

Family Based ◽

Cluster Randomized ◽

Living With Hiv

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Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol

Trials ◽

10.1186/s13063-019-3735-3 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Margo S. Harrison ◽

Saskia Bunge-Montes ◽

Claudia Rivera ◽

Andrea Jimenez-Zambrano ◽

Gretchen Heinrichs ◽

...

Keyword(s):

Randomized Trial ◽

Clinical Care ◽

Cluster Randomized Trial ◽

Routine Care ◽

Postpartum Visit ◽

Postpartum Contraception ◽

Home Setting ◽

Home Based ◽

Cluster Randomized ◽

Long Acting

Abstract Background Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. Methods This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. Discussion A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town which is about an hour away by vehicular travel. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within 3 months of childbirth. The potential implications of this study include that nurses may be able to be trained to safely provide contraceptives, including placing implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period. Trial registration Clinicaltrials.gov, NCT04005391. Retrospectively registered on 1 July 2019.

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Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol

10.21203/rs.2.12494/v2 ◽

2019 ◽

Author(s):

Margo Harrison ◽

Saskia Bunge-Montes ◽

Claudia Rivera ◽

Andrea Jimenez-Zambrano ◽

Gretchen Heinrichs ◽

...

Keyword(s):

Randomized Trial ◽

Clinical Care ◽

Cluster Randomized Trial ◽

Routine Care ◽

Postpartum Visit ◽

Postpartum Contraception ◽

Home Setting ◽

Home Based ◽

Cluster Randomized ◽

Long Acting

Abstract Abstract Background: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth. Methods: This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided. Discussion: A barrier to postpartum contraception is access to medications and devices. Our study removes some access barriers (distance, time, cost) by providing contraception in the home. We also trained community nurses to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town, which is about an hour away by vehicle. Therefore, our study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within three months of childbirth. The potential implications of this study include: nurses may be able to be trained to safely provide contraceptives, including place implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period.

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