HIVPhase 3NCT01233531
Effects of Cash Transfer for the Prevention of HIV in Young South African Women
A Phase 3 study testing monthly cash transfer payments for attending school and B--No cash transfers in people with HIV, run by HIV Prevention Trials Network at 1 site in South Africa.
Trial summary
Cash transfers to young women for staying in school and its effect on acquiring HIV Read more about this study
- Who is it for?
- Ages 13 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- monthly cash transfer payments for attending school and B--No cash transfers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,537 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2011to Mar 2015
- Phase
- Phase 3
- 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 13 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female aged 13 to 20 years.
- Enrolled in grades 8, 9, 10 or 11 at the beginning of the study at schools in the AHDSS study site
- Intending to continue to live in the study site until the end of the follow-up period.
- Be willing and able to consent/assent to all study procedures including HIV and HSV-2 testing.
- Able to read sufficiently to use ACASI.
- Have a bank or post office account or have documentation to be able to open a bank or post office account (i.e., birth certificate, South African National Identification Book, or passport and proof of residence). Post Office accounts will only be required for participants in the Intervention arm.
- Parent/Legal Guardian who lives with young woman, willing and able to consent to all study procedures including HIV and HSV-2 testing.
- Parent/Legal Guardian has a bank or post office account or has documentation to be able to open a bank or post office account (i.e. South African National Identification Book, or passport and proof of residence). Note that the account may be opened in the name of any adult who resides in the household with the young woman.
Who cannot join
- Pregnant by self-report at baseline.
- Married at baseline.
- No parent or legal guardian living in household.
- Any other reason that the staff feels would jeopardize the health or well-being of the participant or staff or would prevent proper conduct of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Cash transfers to young women for staying in school and its effect on acquiring HIV
Read the detailed description
The overall purpose of this study is to determine whether providing cash transfers to young women and their household, conditional on school attendance, reduces young women's risk of acquiring Human Immunodeficiency Virus (HIV). The overall goal of the Conditional Cash Transfer (CCT) intervention is to reduce structural barriers to education with the goal of increasing school attendance of young women, thereby decreasing their HIV risk.
- Conditions
- HIV
- Being tested
- monthly cash transfer payments for attending school, B--No cash transfers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monthly cash transfer payments for attending schoolBehavioural
In the intervention, young women and their households will be randomized in 1:1 ratio to receive monthly cash transfer payments, conditional on the young woman attending school, or to the control arm. Young women will be recruited at the beginning of grades 8 through 11 in the first year of the study.
B--No cash transfersBehavioural
No monthly cash transfers
| Study group | Role | What they receive |
|---|---|---|
| A--Monthly cash transfers | Other | Monthly cash transfer payments Receives: Behavioral: monthly cash transfer payments for attending school |
| B--No cash transfers | Other | No cash transfers. Receives: Behavioral: monthly cash transfer payments for attending school; Behavioral: B--No cash transfers |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Incidence
To determine whether young women who are randomized to receive CCTs conditional on school attendance have a lower incidence of HIV infection over time compared to young women who are not randomized to receive cash transfers.
Measured: 4 years
Secondary outcomes (2)
HSV-2 incidence
To determine whether young women who are randomized to receive CCTs conditional on school attendance have a lower incidence of Herpes Simplex Virus type 2 (HSV-2) infections over time compared to young women who are not randomized to receive cash transfers.
Measured: 4 years
HSV Incidence
To determine whether young women who receive the CCTs report less unprotected sex, fewer number of sexual partners, younger male partners, an older age of coital debut, a lower incidence of self-reported pregnancy, and greater school attendance compared to young women who do not receive the cash transfers.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- HIV Prevention Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Audrey Pettifor, Study chair, University of North CarolinaXavier Gomez-Olive, Principal investigator, Wits Rural Public Health and Health Transitions Research UnitKathleen Kahn, Principal investigator, University of Witwatersrand, South AfricaCatherine McPhail, Principal investigator, Reproductive Health & HIV Research Unit, University of Witwatersrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233531
- Sponsor's protocol ID
- HPTN 068
- Other IDs
- 11710, UM1AI068619
- Status last verified
- Mar 2025
- First submitted
- 1 Nov 2010
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosenberg M, Beidelman E, Chen X, Canning D, Kobayashi L, Kahn K, Pettifor A, Kabudula CW. The impact of a randomized cash transfer intervention on mortality of adult household members in rural South Africa, 2011-2022. Soc Sci Med. 2023 May;324:115883. doi: 10.1016/j.socscimed.2023.115883. Epub 2023 Mar 31.
PubMed 37023659Jayaweera RT, Goin D, Twine R, Neilands TB, Wagner RG, Lippman SA, Kahn K, Pettifor A, Ahern J. Associations between WASH-related violence and depressive symptoms in adolescent girls and young women in South Africa (HPTN 068): a cross-sectional analysis. BMJ Open. 2022 Jul 5;12(7):e061032. doi: 10.1136/bmjopen-2022-061032.
PubMed 35790334DeLong SM, Powers KA, Pence BW, Maman S, Dunkle KL, Selin A, Twine R, Wagner RG, Gomez-Olive FX, MacPhail C, Kahn K, Pettifor A. Longitudinal Trajectories of Physical Intimate Partner Violence Among Adolescent Girls in Rural South Africa: Findings From HPTN 068. J Adolesc Health. 2020 Jul;67(1):69-75. doi: 10.1016/j.jadohealth.2019.12.016. Epub 2020 Feb 13.
PubMed 32061464MacPhail C, Khoza N, Selin A, Julien A, Twine R, Wagner RG, Gomez-Olive X, Kahn K, Wang J, Pettifor A. Cash transfers for HIV prevention: what do young women spend it on? Mixed methods findings from HPTN 068. BMC Public Health. 2017 Jul 11;18(1):10. doi: 10.1186/s12889-017-4513-3.
PubMed 28697762Pettifor A, MacPhail C, Hughes JP, Selin A, Wang J, Gomez-Olive FX, Eshleman SH, Wagner RG, Mabuza W, Khoza N, Suchindran C, Mokoena I, Twine R, Andrew P, Townley E, Laeyendecker O, Agyei Y, Tollman S, Kahn K. The effect of a conditional cash transfer on HIV incidence in young women in rural South Africa (HPTN 068): a phase 3, randomised controlled trial. Lancet Glob Health. 2016 Dec;4(12):e978-e988. doi: 10.1016/S2214-109X(16)30253-4. Epub 2016 Nov 1.
PubMed 27815148
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cash Transfer for the Prevention of HIV in Young South African Women
- ClinicalTrials.gov ID
- NCT01233531
- Acronym / sponsor ID
- HPTN 068
- Conditions
- HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,537 participants (actual)
- Lead sponsor
- HIV Prevention Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Nov 2010 (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.
Cash transfers to young women for staying in school and its effect on acquiring HIV
Detailed description
The overall purpose of this study is to determine whether providing cash transfers to young women and their household, conditional on school attendance, reduces young women's risk of acquiring Human Immunodeficiency Virus (HIV). The overall goal of the Conditional Cash Transfer (CCT) intervention is to reduce structural barriers to education with the goal of increasing school attendance of young women, thereby decreasing their HIV risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A--Monthly cash transfers | Other | Behavioral: monthly cash transfer payments for attending schoolMonthly cash transfer payments |
| B--No cash transfers | Other | Behavioral: monthly cash transfer payments for attending school, Behavioral: B--No cash transfersNo cash transfers. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Female aged 13 to 20 years.
- Enrolled in grades 8, 9, 10 or 11 at the beginning of the study at schools in the AHDSS study site
- Intending to continue to live in the study site until the end of the follow-up period.
- Be willing and able to consent/assent to all study procedures including HIV and HSV-2 testing.
- Able to read sufficiently to use ACASI.
Key exclusion criteria (4 listed)
- Pregnant by self-report at baseline.
- Married at baseline.
- No parent or legal guardian living in household.
- Any other reason that the staff feels would jeopardize the health or well-being of the participant or staff or would prevent proper conduct of the study.
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 |
|---|---|---|
| monthly cash transfer payments for attending schoolIn the intervention, young women and their households will be randomized in 1:1 ratio to receive monthly cash transfer payments, conditional on the young woman attending school, or to the control arm. Young women will be recruited at the beginning of grades 8 through 11 in the first year of the study. | Behavioural | A--Monthly cash transfers, B--No cash transfers |
| B--No cash transfersNo monthly cash transfers | Behavioural | B--No cash transfers |
Primary outcome
HIV Incidence
Time frame: 4 years
To determine whether young women who are randomized to receive CCTs conditional on school attendance have a lower incidence of HIV infection over time compared to young women who are not randomized to receive cash transfers.
2 secondary outcomes
HSV-2 incidence
Time frame: 4 years
HSV Incidence
Time frame: 4 years
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 Mar 2025.
- Derived from this study: PubMed 37023659Rosenberg M, Beidelman E, Chen X, Canning D, Kobayashi L, Kahn K, Pettifor A, Kabudula CW. The impact of a randomized cash transfer intervention on mortality of adult household members in rural South Africa, 2011-2022. Soc Sci Med. 2023 May;324:115883. doi: 10.1016/j.socscimed.2023.115883. Epub 2023 Mar 31.
- Derived from this study: PubMed 35790334Jayaweera RT, Goin D, Twine R, Neilands TB, Wagner RG, Lippman SA, Kahn K, Pettifor A, Ahern J. Associations between WASH-related violence and depressive symptoms in adolescent girls and young women in South Africa (HPTN 068): a cross-sectional analysis. BMJ Open. 2022 Jul 5;12(7):e061032. doi: 10.1136/bmjopen-2022-061032.
- Derived from this study: PubMed 32061464DeLong SM, Powers KA, Pence BW, Maman S, Dunkle KL, Selin A, Twine R, Wagner RG, Gomez-Olive FX, MacPhail C, Kahn K, Pettifor A. Longitudinal Trajectories of Physical Intimate Partner Violence Among Adolescent Girls in Rural South Africa: Findings From HPTN 068. J Adolesc Health. 2020 Jul;67(1):69-75. doi: 10.1016/j.jadohealth.2019.12.016. Epub 2020 Feb 13.
- Derived from this study: PubMed 28697762MacPhail C, Khoza N, Selin A, Julien A, Twine R, Wagner RG, Gomez-Olive X, Kahn K, Wang J, Pettifor A. Cash transfers for HIV prevention: what do young women spend it on? Mixed methods findings from HPTN 068. BMC Public Health. 2017 Jul 11;18(1):10. doi: 10.1186/s12889-017-4513-3.
- Derived from this study: PubMed 27815148Pettifor A, MacPhail C, Hughes JP, Selin A, Wang J, Gomez-Olive FX, Eshleman SH, Wagner RG, Mabuza W, Khoza N, Suchindran C, Mokoena I, Twine R, Andrew P, Townley E, Laeyendecker O, Agyei Y, Tollman S, Kahn K. The effect of a conditional cash transfer on HIV incidence in young women in rural South Africa (HPTN 068): a phase 3, randomised controlled trial. Lancet Glob Health. 2016 Dec;4(12):e978-e988. doi: 10.1016/S2214-109X(16)30253-4. Epub 2016 Nov 1.
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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.
Audrey Pettifor study chair
University of North Carolina
Xavier Gomez-Olive principal investigator
Wits Rural Public Health and Health Transitions Research Unit
Kathleen Kahn principal investigator
University of Witwatersrand, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing monthly cash transfer payments for attending school and B--No cash transfers in people with HIV, run by HIV Prevention Trials Network at 1 site in South Africa.
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 8 inclusion and 4 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 Mar 2025. 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 South Africa. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HIV Incidence (time frame: 4 years). 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 NCT01233531, which also lists 5 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 Mar 2025.