HIVNCT01838005
Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services
A study testing Conditional cash transfer in people with HIV, run by University of North Carolina, Chapel Hill at 1 site in Republic of the Congo.
Trial summary
The goals of the proposed study are to: 1) test whether small, increasing cash payments to HIV-infected pregnant women, on the condition that they attend scheduled clinic visits and receive proposed services, will increase the proportion of women who receive the most effective antiretroviral regimen they are eligible… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Conditional cash transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- Apr 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed as HIV-positive
- Pregnant between 28 and 32 weeks of gestation (>27 and <32 completed weeks of pregnancy)
- Intend to stay in Kinshasa through delivery and six weeks postpartum
- Able and willing to participate (provide informed consent)
Who cannot join
- Women will be excluded from the study if they are severely ill and require extended hospitalization or need to be cared for at a referral hospital out of the PMTCT network
Trial locations and contacts
1 site in 1 country.
Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa, Kinshasa
About this study
The goals of the proposed study are to: 1) test whether small, increasing cash payments to HIV-infected pregnant women, on the condition that they attend scheduled clinic visits and receive proposed services, will increase the proportion of women who receive the most effective antiretroviral regimen they are eligible for by the time of delivery, and 2) elucidate factors that facilitate or inhibit the uptake and adherence to the PMTCT cascade, and to what extent the conditional cash payment program addresses these factors.
This intervention will be implemented and evaluated within our well-established PMTCT program in Kinshasa, Democratic Republic of Congo (DRC),
- Conditions
- HIV
- Being tested
- Conditional cash transfer
- Keywords
- Contingency management, conditional cash transfer, PMTCT, Retention, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditional cash transferBehavioural
Also called Contingency management
Eligible women randomized to the intervention group will receive the standard of care plus small and increasing cash payments, on the condition that they attend scheduled clinic visits on time (+/-5days), accept HIV services, deliver in a health facility, and at six weeks postpartum adhere to prescribed infant prophylactic drugs (cotrimoxazole, extended NVP) and provide blood sample for DNA PCR infant early HIV diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Routine implementation of the national PMTCT guidelines which are an adaptation of the WHO's "Option A" |
| Conditional Cash Transfer | Experimental | Financial incentive to attend regular clinic visits and receive PMTCT care Receives: Behavioral: Conditional cash transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of women who were adherent to all conditionalities and received the most effective ARV intervention they were eligible to receive and delivered at an affiliated maternity
At each monthly visit starting at randomization (28 weeks), participants will be evaluated for the following conditionalities:
- attended the scheduled visit on time (+/- 5 days)
- accept HIV status and services proposed to them
- return to deliver in the clinic At the end of the follow-up (6 weeks post-partum)the proportion of participants who adhered to all these conditions will be calculated for each study group
Measured: 6 weeks postpartum
Secondary outcomes (3)
Mother to child transmission rate at six weeks and HIV-free survival.
Proportion of HIV-exposed infant who tested positive at 6 week postpartum
Measured: 6 weeks post partum
HIV-free survival at 18 month.
Proportion of children born to HIV+ enrolled mothers who are alive and non infected with HIV
Measured: 18 months porstpartum
Proportion of HIV-exposed infants who at their six week visit received extended Nevirapine (NVP) had a DNA PCR test
Proportion of infants born to HIV-infected participants who at 6 weeks postpartum are receiving the extended nevirapine prophylaxis and have been tested for HIV
Measured: 6 weeks Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kinshasa School of Public Health
- Responsible party
- Sponsor
- Investigators
- Marcel Yotebieng, MD, Principal investigator, Ohio State UniversityEmile W Okitolonda, MD, Principal investigator, Kinshasa School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838005
- Sponsor's protocol ID
- 12-1676
- Other IDs
- 1R01HD075171-01
- Status last verified
- Jan 2017
- First submitted
- 22 Mar 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Yotebieng M, Moracco KE, Thirumurthy H, Edmonds A, Tabala M, Kawende B, Wenzi LK, Okitolonda EW, Behets F. Conditional Cash Transfers Improve Retention in PMTCT Services by Mitigating the Negative Effect of Not Having Money to Come to the Clinic. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):150-157. doi: 10.1097/QAI.0000000000001219.
PubMed 27787342Yotebieng M, Thirumurthy H, Moracco KE, Kawende B, Chalachala JL, Wenzi LK, Ravelomanana NL, Edmonds A, Thompson D, Okitolonda EW, Behets F. Conditional cash transfers and uptake of and retention in prevention of mother-to-child HIV transmission care: a randomised controlled trial. Lancet HIV. 2016 Feb;3(2):e85-93. doi: 10.1016/S2352-3018(15)00247-7.
PubMed 26847230Yotebieng KA, Fokong K, Yotebieng M. Depression, retention in care, and uptake of PMTCT service in Kinshasa, the Democratic Republic of Congo: a prospective cohort. AIDS Care. 2017 Mar;29(3):285-289. doi: 10.1080/09540121.2016.1255708. Epub 2016 Nov 6.
PubMed 27819151Saleska JL, Turner AN, Gallo MF, Shoben A, Kawende B, Ravelomanana NLR, Thirumurthy H, Yotebieng M. Role of temporal discounting in a conditional cash transfer (CCT) intervention to improve engagement in the prevention of mother-to-child transmission (PMTCT) cascade. BMC Public Health. 2021 Mar 10;21(1):477. doi: 10.1186/s12889-021-10499-0.
PubMed 33691667
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditional Cash Transfers to Increase Uptake of and Retention of PMTCT Services
- ClinicalTrials.gov ID
- NCT01838005
- Acronym / sponsor ID
- 12-1676
- Conditions
- HIV
- Keywords
- Contingency management, conditional cash transfer, PMTCT, Retention, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kinshasa School of Public Health
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of the proposed study are to: 1) test whether small, increasing cash payments to HIV-infected pregnant women, on the condition that they attend scheduled clinic visits and receive proposed services, will increase the proportion of women who receive the most effective antiretroviral regimen they are eligible for by the time of delivery, and 2) elucidate factors that facilitate or inhibit the uptake and adherence to the PMTCT cascade, and to what extent the conditional cash payment program addresses these factors.
This intervention will be implemented and evaluated within our well-established PMTCT program in Kinshasa, Democratic Republic of Congo (DRC),
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Routine implementation of the national PMTCT guidelines which are an adaptation of the WHO's "Option A" |
| Conditional Cash Transfer | Experimental | Behavioral: Conditional cash transferFinancial incentive to attend regular clinic visits and receive PMTCT care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed as HIV-positive
- Pregnant between 28 and 32 weeks of gestation (>27 and <32 completed weeks of pregnancy)
- Intend to stay in Kinshasa through delivery and six weeks postpartum
- Able and willing to participate (provide informed consent)
Key exclusion criteria (1 listed)
- Women will be excluded from the study if they are severely ill and require extended hospitalization or need to be cared for at a referral hospital out of the PMTCT network
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditional cash transferAlso: Contingency managementEligible women randomized to the intervention group will receive the standard of care plus small and increasing cash payments, on the condition that they attend scheduled clinic visits on time (+/-5days), accept HIV services, deliver in a health facility, and at six weeks postpartum adhere to prescribed infant prophylactic drugs (cotrimoxazole, extended NVP) and provide blood sample for DNA PCR infant early HIV diagnosis. | Behavioural | Conditional Cash Transfer |
Primary outcome
proportion of women who were adherent to all conditionalities and received the most effective ARV intervention they were eligible to receive and delivered at an affiliated maternity
Time frame: 6 weeks postpartum
At each monthly visit starting at randomization (28 weeks), participants will be evaluated for the following conditionalities: 1. attended the scheduled visit on time (+/- 5 days) 2. accept HIV status and services proposed to them 3. return to deliver in the clinic At the end of the follow-up (6 weeks post-partum)the proportion of participants who adhered to all these conditions will be calculated for each study group
3 secondary outcomes
Mother to child transmission rate at six weeks and HIV-free survival.
Time frame: 6 weeks post partum
HIV-free survival at 18 month.
Time frame: 18 months porstpartum
Proportion of HIV-exposed infants who at their six week visit received extended Nevirapine (NVP) had a DNA PCR test
Time frame: 6 weeks Postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Results publication: PubMed 27787342Yotebieng M, Moracco KE, Thirumurthy H, Edmonds A, Tabala M, Kawende B, Wenzi LK, Okitolonda EW, Behets F. Conditional Cash Transfers Improve Retention in PMTCT Services by Mitigating the Negative Effect of Not Having Money to Come to the Clinic. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):150-157. doi: 10.1097/QAI.0000000000001219.
- Results publication: PubMed 26847230Yotebieng M, Thirumurthy H, Moracco KE, Kawende B, Chalachala JL, Wenzi LK, Ravelomanana NL, Edmonds A, Thompson D, Okitolonda EW, Behets F. Conditional cash transfers and uptake of and retention in prevention of mother-to-child HIV transmission care: a randomised controlled trial. Lancet HIV. 2016 Feb;3(2):e85-93. doi: 10.1016/S2352-3018(15)00247-7.
- Results publication: PubMed 27819151Yotebieng KA, Fokong K, Yotebieng M. Depression, retention in care, and uptake of PMTCT service in Kinshasa, the Democratic Republic of Congo: a prospective cohort. AIDS Care. 2017 Mar;29(3):285-289. doi: 10.1080/09540121.2016.1255708. Epub 2016 Nov 6.
- Derived from this study: PubMed 33691667Saleska JL, Turner AN, Gallo MF, Shoben A, Kawende B, Ravelomanana NLR, Thirumurthy H, Yotebieng M. Role of temporal discounting in a conditional cash transfer (CCT) intervention to improve engagement in the prevention of mother-to-child transmission (PMTCT) cascade. BMC Public Health. 2021 Mar 10;21(1):477. doi: 10.1186/s12889-021-10499-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Yotebieng, MD principal investigator
Ohio State University
Emile W Okitolonda, MD principal investigator
Kinshasa School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conditional cash transfer in people with HIV, run by University of North Carolina, Chapel Hill at 1 site in Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of women who were adherent to all conditionalities and received the most effective ARV intervention they were eligible to receive and delivered at an affiliated maternity (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838005, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.