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| Name | Class |
|---|---|
| University of Nairobi | OTHER |
| Kenyatta National Hospital | OTHER_GOV |
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The investigators are conducting a 3-arm randomized trial comparing the effects of unidirectional SMS (ie: "push" messaging to participant) vs. bidirectional SMS dialogue between participant and provider vs. control (no SMS) among HIV-infected Kenyan mothers in Kenyan PMTCT-ART for outcomes of ART adherence and retention in care.
The investigators will compare trial arms for impact on maternal retention, adherence, virologic failure and resistance and infant HIV or HIV-free survival.
The investigators will determine correlates of maternal loss to follow-up and virologic failure and correlates of infant HIV in the overall study and stratified by trial arm. In the bidirectional SMS arm, the investigators will determine the rate of SMS interactivity, impact of critical time-points on messaging, and characteristics of high and low 'interactors'.
The investigators will determine cost-effectiveness of unidirectional and bidirectional SMS interventions. These data will contribute a potential scale-able strategy to improve PMTCT-ART as programs aspire to 'virtual elimination' of infant HIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two-way SMS | Experimental | Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse |
|
| One-Way SMS | Experimental | Participants will receive weekly push SMS messaging |
|
| Control | No Intervention | Participants will receive standard of care (no intervention) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS messaging | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Virologic Failure | Prevalence of virologic failure (HIV RNA ≥1000 c/ml) after the first 4 months post-ART will be compared between study arms using Generalized Estimating Equations (GEE) with log-binomial link. | 2 years postpartum |
| Retention in Care | Timely clinic visit attendance during follow-up from enrollment in pregnancy to 12 and 24 months postpartum will be compared between study arms using GEE with log-binomial link. | Assessed at 24 months postpartum |
| Loss to Follow-up | The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression. | Assessed at 24 months postpartum |
| Infant HIV-free Survival | Incidence of infant HIV acquisition or death (events per person-time of follow-up) will be compared between study arms using Cox proportional hazards regression. | 2 years postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal ART Adherence | ART adherence, defined as the proportion of days "covered" by ART between pharmacy refills, will be dichotomized and compared between arms using GEE with log-binomial link. | 2 years postpartum |
| Maternal ART Resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace John-Stewart | UW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahero District Hospital | Ahero | Kenya | ||||
| Bondo District Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28315480 | Background | Drake AL, Unger JA, Ronen K, Matemo D, Perrier T, DeRenzi B, Richardson BA, Kinuthia J, John-Stewart G. Evaluation of mHealth strategies to optimize adherence and efficacy of Option B+ prevention of mother-to-child HIV transmission: Rationale, design and methods of a 3-armed randomized controlled trial. Contemp Clin Trials. 2017 Jun;57:44-50. doi: 10.1016/j.cct.2017.03.007. Epub 2017 Mar 14. | |
| 29254362 |
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825 participants were enrolled but it was later identified that one participant was enrolled twice. Only one of these records is included in analysis for a total participant number of 824
Between November 22, 2015 and May 4, 2017, participants were recruited from 6 public maternal child health (MCH) clinics in Kenya: 2 in peri-urban Nairobi County and 4 in rural Siaya, Kisumu, and Homa Bay Counties
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| ID | Title | Description |
|---|---|---|
| FG000 | Two-way SMS | Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse |
| FG001 | One-Way SMS | Participants will receive weekly push SMS messaging |
| FG002 | Control | Participants will receive standard of care (no intervention) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Two-way SMS | Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse SMS messaging |
| BG001 | One-Way SMS | Participants will receive weekly push SMS messaging SMS messaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Virologic Failure | Prevalence of virologic failure (HIV RNA ≥1000 c/ml) after the first 4 months post-ART will be compared between study arms using Generalized Estimating Equations (GEE) with log-binomial link. | Participants with VL data available >=4 months post-ART initiation | Posted | Count of Units | VL measurements | 2 years postpartum | VL measurements | VL measurements |
|
Pregnancy until 2 years postpartum visit (period of study enrollment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Two-way SMS | Participants will receive weekly push SMS messaging with a questions and have the ability to text back to the study nurse |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maternal death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage/stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keshet Ronen | University of Washington | 206-685-4363 | keshet@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 30, 2018 | Aug 26, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2020 | Sep 29, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2017 | Aug 26, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression.
| 2 years postpartum |
| Maternal Perceptions of Intervention and Care Received | Qualitative interviews at exit | 2 years postpartum |
| Bondo |
| Kenya |
| Mathare City Council Clinic | Nairobi | Kenya |
| Riruta Health Centre | Nairobi | Kenya |
| Rachuonyo sub-County Hospital | Oyugis | Kenya |
| Siaya County Referral Hospital | Siaya | Kenya |
| Background |
| Ronen K, Unger JA, Drake AL, Perrier T, Akinyi P, Osborn L, Matemo D, O'Malley G, Kinuthia J, John-Stewart G. SMS messaging to improve ART adherence: perspectives of pregnant HIV-infected women in Kenya on HIV-related message content. AIDS Care. 2018 Apr;30(4):500-505. doi: 10.1080/09540121.2017.1417971. Epub 2017 Dec 18. |
| 31752872 | Background | Lewis K, Harrington EK, Matemo D, Drake AL, Ronen K, O'Malley G, Kinuthia J, John-Stewart G, Unger JA. Utilizing perspectives from HIV-infected women, male partners and healthcare providers to design family planning SMS in Kenya: a qualitative study. BMC Health Serv Res. 2019 Nov 21;19(1):870. doi: 10.1186/s12913-019-4708-7. |
| 30026177 | Background | Fairbanks J, Beima-Sofie K, Akinyi P, Matemo D, Unger JA, Kinuthia J, O'Malley G, Drake AL, John-Stewart G, Ronen K. You Will Know That Despite Being HIV Positive You Are Not Alone: Qualitative Study to Inform Content of a Text Messaging Intervention to Improve Prevention of Mother-to-Child HIV Transmission. JMIR Mhealth Uhealth. 2018 Jul 19;6(7):e10671. doi: 10.2196/10671. |
| 34579601 | Derived | Osborn L, Ronen K, Larsen AM, Richardson B, Khasimwa B, Chohan B, Matemo D, Unger J, Drake AL, Kinuthia J, John-Stewart G. Antenatal depressive symptoms in Kenyan women living with HIV: contributions of recent HIV diagnosis, stigma, and partner violence. AIDS Care. 2022 Jan;34(1):69-77. doi: 10.1080/09540121.2021.1981216. Epub 2021 Sep 27. |
| 34029338 | Derived | Kinuthia J, Ronen K, Unger JA, Jiang W, Matemo D, Perrier T, Osborn L, Chohan BH, Drake AL, Richardson BA, John-Stewart G. SMS messaging to improve retention and viral suppression in prevention of mother-to-child HIV transmission (PMTCT) programs in Kenya: A 3-arm randomized clinical trial. PLoS Med. 2021 May 24;18(5):e1003650. doi: 10.1371/journal.pmed.1003650. eCollection 2021 May. |
| Withdrawal by Subject |
|
| BG002 | Control | Participants will receive standard of care (no intervention) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| On antiretroviral therapy (ART) >=4 months | Count of Participants | Participants |
|
| Viral load (VL) >=1000 at enrollment | Count of Participants | Participants |
|
| Shares phone | Count of Participants | Participants |
|
| Employed | Missing responses | Count of Participants | Participants |
|
| Primigravida | Count of Participants | Participants |
|
| OG002 | Control | Participants will receive standard of care (no intervention) |
|
|
| Primary | Retention in Care | Timely clinic visit attendance during follow-up from enrollment in pregnancy to 12 and 24 months postpartum will be compared between study arms using GEE with log-binomial link. | Participants with clinic visits scheduled during the study period | Posted | Count of Units | Scheduled visits | Assessed at 24 months postpartum | Scheduled visits | Scheduled visits |
|
|
|
| Primary | Loss to Follow-up | The proportions of women lost to follow-up at 12 and 24 months postpartum will be compared between study arms by log-binomial regression. | Participants still enrolled in the study at 24 months postpartum | Posted | Count of Participants | Participants | Assessed at 24 months postpartum |
|
|
|
| Primary | Infant HIV-free Survival | Incidence of infant HIV acquisition or death (events per person-time of follow-up) will be compared between study arms using Cox proportional hazards regression. | Participants with live-born infants | Posted | Number | Events | 2 years postpartum | Person-years | Person-years |
|
|
|
| Secondary | Maternal ART Adherence | ART adherence, defined as the proportion of days "covered" by ART between pharmacy refills, will be dichotomized and compared between arms using GEE with log-binomial link. | Participants with pharmacy refill data available | Posted | Count of Units | Refill visits | 2 years postpartum | Refill visits | Refill visits |
|
|
|
| Secondary | Maternal ART Resistance | Incidence of drug resistance on ART will be compared between study arms using Cox proportional hazards regression. | Participants without ART resistance at enrollment | Posted | Count of Participants | Participants | 2 years postpartum |
|
|
|
| Secondary | Maternal Perceptions of Intervention and Care Received | Qualitative interviews at exit | Not Posted | 2 years postpartum | Participants |
| 5 |
| 276 |
| 32 |
| 276 |
| 15 |
| 276 |
| EG001 | One-Way SMS | Participants will receive weekly push SMS messaging | 3 | 271 | 18 | 271 | 17 | 271 |
| EG002 | Control | Participants will receive standard of care (no intervention) | 4 | 277 | 24 | 277 | 14 | 277 |
| Infant death | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal hospitalization | General disorders | Systematic Assessment |
|
| Infant hospitalization | General disorders | Systematic Assessment |
|
| Physical or sexual abuse | Social circumstances | Systematic Assessment |
|
| Psychological distress | Psychiatric disorders | Systematic Assessment |
|
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| D001519 | Behavior |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Male |
|