Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01589965 |
| Other study ID # |
100 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 0
|
| First received |
April 19, 2010 |
| Last updated |
May 1, 2012 |
| Start date |
February 2010 |
| Est. completion date |
June 2012 |
Study information
| Verified date |
May 2012 |
| Source |
Bocconi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Italy: Ethics Committee |
| Study type |
Interventional
|
Clinical Trial Summary
The HIV/AIDS epidemic is a major concern in many countries. The epidemic is especially acute
in Lesotho where roughly one quarter of the population is infected by HIV/AIDS. In Lesotho,
and elsewhere, new innovative approaches to induce safer sexual behavior have been
desperately called for, particularly in view of the limited impact that existing prevention
schemes have had on the trajectory of the HIV/AIDS epidemic.
One of the key questions is to understand why individuals get involved in short-term risky
sexual behavior when the potential long-term cost of becoming HIV infected is so high? A
follow-up question is what replicable and feasible interventions can affect this trade-off
between short and long run returns? The primary aim of this study is to evaluate whether the
use of short-term financial incentives can affect this trade-off, thereby influencing young
individuals' decisions with respect to sexual and reproductive health behavior, and thus in
the end reduce HIV incidence rates. The investigators will study this question using a
sample of population attending served by New Start Voluntary Counseling and Testing (VCT)
sites that a local NGO, Population Service International (PSI), has already implemented in
Lesotho.
The investigators propose to conduct a randomized controlled trial to test whether adding a
financial incentive to remain STI-negative in the form of a lottery can promote safer sexual
activity. The lotteries will work as follows: if the individual is tested negative on a set
of curable STIs, she will get a lottery ticket with the chance to win a "big" prize. If she
is tested positive, she will receive free treatment, but no lottery ticket. If an individual
who tested positive is cured, she can come back in the lottery system and get a later chance
to win the lottery ticket if she remains STI-negative. The outcome will be to measure the
impact of financial incentives on HIV incidence after two years.
The results of this research project will be disseminated through academic and non-academic
conferences, workshops, publications in academic journals, and also in policy journals with
the aim to reach out to policy makers outside the research community.
Description:
Lesotho has the third-highest HIV prevalence in the world at 23.2%. Many HIV prevention
initiatives are currently going on in the country. The proposed impact evaluation responds
to the urgent need to find innovative approaches to promote safer sexual behaviors among
youths in Lesotho. In particular, the project will be implemented through the New Start
Voluntary Counseling and Testing (VCT) sites established by PSI in the country.
PSI, the implementing agency, has 5 static New Start VCT sites nationally in 5 out of the 10
districts in Lesotho. They are located in the main camp town of each district. Each of these
sites has vehicles and tents that are used for outreach services. Outreach activities aim at
targeting more specific groups of the population who are generally at higher risk of HIV
infection. For example, rural and peri-urban villages (within 60 km radius from the VCT
sites, working places (garment factories, phone companies, etc.)) and schools. The present
randomized evaluation aims at targeting youths in rural and peri-urban villages.
PSI Lesotho has an extensive experience of working in the HIV prevention sector and it is
currently involved in various HIV prevention activities, including, in particular, provision
of VCT services and condom distribution.
3. Research objective and Motivation The result of traditional information campaigns (like
ABC-Abstinence, Be Faithful and use Condom) on sexual behavioral changes is not conclusive.
Although, anecdotal evidence shows that it has resulted in some changes, for example,
interventions focusing on condoms use have resulted in increasing condoms during commercial
and sexual encounters, there is no rigorous evidence actually showing a significant
reduction in HIV prevalence in most Southern Africa countries.
Perhaps the reason for this resides in some differences in sexual behavior in Africa (e.g.
it is much more common to have concurrent partnerships that can overlap for significant
time) and so the information campaigns are not focusing on the right messages and thus not
affecting behavior where it matters the most. Or maybe, as recent literature suggests people
tend to delay activities that are a little bit unpleasant in the present (like protecting
themselves) even if they have very large returns in the future. People may not be aware of
the long-term benefits of safe sexual behaviors. Alternatively, they give a lot of weight to
short-term gains, either because they discount the future heavily or have preferences that
might be inconsistent over time, with a strong preference for the present.
What replicable and feasible interventions can affect this trade-off between short and long
run returns? Can the introduction of a small but "short term" reward promote safer sexual
behaviors? This intervention aims at contrasting the difference between a reward in the next
4 months (a lottery ticket) and a reward 10 years later (being HIV negative). The main issue
is the interval between the sexual activity and the lottery. To gauge the extent of
participation in the lottery, the correct interval time among lottery draws, and the impact
on behavioural changes, the investigators plan to do a short qualitative study a couple of
months before the beginning of the project.
The research objective is to test and rigorously evaluate whether the introduction of small
financial rewards in the short term can promote safer sexual behaviour in general, and
reduce HIV incidence in particular, in a high risk environment.
The results of the evaluation are expected to be an important input in designing effective
HIV prevention in Lesotho. Furthermore, a credible impact evaluation is also a global public
good in the sense that it can offer reliable guidance to international organizations,
governments, donors, and nongovernmental organizations in their ongoing search for effective
HIV prevention programs.
4. Methods and Evaluation Design 4.1 Evaluation Design The investigators are proposing to
conduct a randomized controlled field trial to rigorously test whether short-term financial
incentives have an impact on sexual behavior and the incidence of HIV and a small set of
curable STIs of youth who live in villages that are served by outreach sessions of New Start
VCT in Lesotho.
The underlying question for the study is why individuals get involved in short-term risky
sexual behavior when the potential long-term cost of becoming HIV infected is so high, which
clearly is the case in Lesotho. It appears like individuals, to the extent that they have
not been coerced into having sex (which unfortunately is also a common problem); put a lot
of weight on short-term gains at the expense of long run benefits. If this is the case,
short run financial incentives may affect individual's trade-off between short and long run
returns. In fact, there exists some preliminary evidence that small (financial) incentives
associated with activities that have very high returns in the future can result in
significant change in behavior. However, there is little (no) evidence that such an
incentive scheme will work when it comes to sexual behavior.
Thus, the main hypothesis to be tested is that a system of rapid feedback and positive
reinforcement using cash as an incentive can effectively lower risky sexual activity and
reduce rates of HIV transmission. The primary outcomes for evaluating impact will be a
sub-set of sexually-transmitted infections (STIs), Syphilis and Trichomoniasis, that are
prevalent in the population and have been incontrovertibly linked to risky sexual activity.
Each of these STIs is curable. This is a critical point, since enrollees who test positive
for an STI can continue to participate in the study after they have been treated and cured
of the infection. Thus, learning is encouraged through positive reinforcement, and mistakes
can be corrected and overcome.
The investigators propose to test this hypothesis through the introduction of financial
incentives in the form of a lottery to remain/become STI-negative, which the researchers
believe is both replicable and relatively easy to scale-up. Lotteries are also more valued
by risk-takers and these individuals might also be the ones with the most risky sexual
behavior, thus providing additional incentives would reach the most important group. The
presumption is that the financial incentive will influence individuals' trade-off between
short and long run returns with respect to sexual behavior.
The sample population will consist of youth aged 18-30 who live in villages that are served
by outreach activities in rural and peri-urban villages implemented by the VCT centers in
Lesotho The investigators aim at a study population of about 5,000 (see section 4.3 for
details). To the extent demand will exceed supply; the researchers will randomly choose the
participants.
In a randomized controlled field trial the sample population is randomly divided into a
treatment group (individuals that will have a chance to participate in the lottery) and a
comparison (individuals that will not take part in the lottery) group. Here, the
randomization will be at the individual level. 30% of the individuals will be assigned to
the first treatment group, 30% to the second treatment group, and 40% to the control group.
The two treatment groups only differ on the amount of winnings possible in the lottery. The
control group will be slightly larger to control for the possibility of attrition. Since
treatment has been randomly assigned, and provided that the sample contains a sufficiently
large number of individuals, units assigned to the treatment and comparison groups are
similar in expectations before the intervention. The causal effect of the intervention can
therefore be gauged by comparing mean outcomes in the treatment and comparison groups after
the intervention.
The random assignment to the control and treatment groups will be done in a transparent way,
for example by drawing from a bag which individual will be in the treatment and in the
control groups Not only does randomization guarantee internal validity, it is also typically
a fair way to allocate participants across the treatment and the comparison groups.
Individuals both in the treated and in the control groups will receive free sexual health
discussion sessions as part of the PSI prevention and treatment program, free HIV and STI
testing, free STI treatment (for individuals tested positive), and free counseling before
and after each STI/HIV test. PSI also will provide free male and female condoms.
Individuals in the treatment groups will be eligible to participate in a lottery if they are
tested STI negative. There will be testing and lottery draw every four months. Participants
will know in advance the amount of the lottery reward. The lottery will be drawn among all
the STI negative people in each villages. There will be 4 winners (i.e. two men and two
women) in each village. The exact details on the type and the size of the reward will be
more precisely decided during the pilot of the project. The focus on STI status as a
condition for participation in the lottery, rather than on HIV status, is primarily based on
ethical consideration. By focusing on STIs that are curable, the investigators can also
study how the intervention affects behavior of both HIV-positive and HIV-negative
participants. STI-positive individuals, who receive treatment and are cured, will be
eligible to participate in future lottery draws.
The proposal calls for seven follow-up surveys, one after a 4-month period. The
investigators aim at surveying twice the sample of around 5,000 participants. To generate
more precise estimates of the impact of the intervention, a baseline survey will also be
implemented. The information from the baseline survey will also assist in stratifying the
sample and will be used to study heterogeneous effects. In order to minimize attrition
during the project, the researchers will collect data on names, addresses and phone numbers
of the participants in a way to preserve confidentiality and not to decrease their
willingness to participate (see section 5 for details).
The design of this experiment avoids the usual complications of selection and reporting bias
because it randomized individual incentive to learn STIs status. However, there will be
self-selection of people who choose to decide to participate in the study, because, for
example, they are more motivated and aware and perhaps knowledgeable about their options (in
case they are HIV positive) compared to someone who has tested. Study participants will also
choose whether to know their HIV status or not. However, counseling will be provided to
assist them to make an informed decision and accept their results. Those are mainly problems
of external validity. The investigators are aware of these problems but in practice, they
are difficult to avoid, since the investigators cannot impose this study on a representative
sample of the population.
